• Miles Hutchinson Recorded
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    Price: ¤149.00
    by: Miles Hutchinson
    Introduction to Sales and Use Taxation
    Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Hot Issues in Determining Multi-State Sales Tax Nexus
    Gain valuable insight into the complex issues of interstate sales and the obligations of out-of-state (foreign) sellers to collect the destination state’s taxes. Get up-to-date information about the retailing giants and their fights with the various states. Take a ring-side seat with an expert who will share the anticipated outcomes.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Complying with FATCA - the Foreign Accounts Tax Compliance Act
    Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.

  • Rodriguez Gonzalez Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Rodriguez Gonzalez
    Compliance and Continual Improvement, Tools of the Trade
    Meeting regulatory specifications is the minimum that a business needs to get done to operate in a market without falling in the risk of non-compliance. This type of requirements are analog to those required by the customers, and the Continual Improvement tools used for quality control are interchangeable. The idea of this webinar is to provide a visualization of regulatory requirements from a Continual Improvement angle. Ideas and examples of how Continual Improvement tools can be utilized to facilitate the management of regulatory issues will be provided.

  • Norman G. Marriott Recorded
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    Duration:60 Minutes
    Price: ¤149.00
    by: Norman G. Marriott
    Foodservice Sanitation
    Foodservice sanitation is the maintenance of clean conditions in food production, preparation, and serving areas as well as the practice of proper personal cleanliness and hygienic practices. As the foodservice industry has grown, methods of food production, processing, distribution, and preparation have changed. Major changes have included increased prepackaged food as partially or fully prepared bulk or pre-portioned servings and centralized food production.

  • Denise Cicchella Recorded
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    Price: ¤149.00
    by: Denise Cicchella
    Foreign Corrupt Practices Act - Audits Role
    The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.

  • Fred Vacelet Recorded
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    Price: ¤149.00
    by: Fred Vacelet
    Operational Risk - Beyond Regulatory Constraints
    In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small losses or improving efficiency without consideration for high-impact risks.

  • Dev Raheja Recorded
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    Price: ¤149.00
    by: Dev Raheja
    System Safety Engineering
    Today we are not dealing with a system. We are dealing with system-of-systems. Safety has become too complex with millions of lines of codes in hardware components and interoperability risks of such components. Not only design engineers should have this knowledge but every technical employee and every manager must have thorough knowledge of the science of system safety.

  • Stephen Alvania Recorded
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    Price: ¤149.00
    by: Stephen Alvania
    Fundamental ATC Organization, Structure, and Concepts
    Many people believe that communications, navigation, surveillance, and automation technologies are the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely. In reality, air traffic control is the process by which many thousands of airplanes are provided separation services as they climb, descend, and cross paths and altitudes as they travel from any one of thousands of departure airports to any one of thousands of destination airports daily.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    ATC Radar Approach Control (TRACON)
    Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Mastering the Power of Sensitivity Tools in Financial Modeling
    Join us for 90 minutes to learn how to put the powerful sensitivity tools of Microsoft Excel to work in your models. Learn the top 20 best practices of solid model design, development and delivery. Seasoned financial analyst, Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools.

  • Roger Nakata Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Roger Nakata
    Air Traffic Control and Airport Operation Coordination
    Airport effectiveness is dependent on each airport entity’s participation and effectiveness at the airport. When information is not shared or understood by even one entity, it creates safety and efficiency issues at the airport. Whether you are an Airline, Airport Operations, Airport Manager, Air Traffic Control or any other entity on the airport, you must have a complete understanding of your requirements of the operations at the airport. You must have a good understanding of the needs and requirements of the other entities. Ignorance and misunderstandings compromises safety and decreases the efficiency at the airport.

  • Stuart Gardner Recorded
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    Price: ¤149.00
    by: Stuart Gardner
    Project Management - Auditing Problem Projects
    Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to.

  • Roger Nakata Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Roger Nakata
    Understanding Next Gen (FAA New Technology)
    FAA Definition: NextGen is the evolution of the NAS to a more advance state, which makes better use of technology and design to more efficiently meet transportation needs.

  • Anthony Goode Recorded
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    Price: ¤149.00
    by: Anthony Goode
    Industrial Technical Benefits- Canada's New Approach to Offsets for Defence Procurement
    Industrial Technical Benefits- Canada's new approach to offsets for defence procurement: As part of the recently announced Defence Procurement Strategy, the Canadian Government has introduced a new industrial benefits policy that is designed to leverage purchases of defence equipment to create jobs and economic growth in Canada. Companies pursuing defence procurement opportunities in Canada will be required to submit value propositions, include key industrial capabilities (KIC) in their proposal and submit detailed industrial and technological benefits (ITB) plans with their proposals that will then be rated by the Government.

  • Lynne Hare Recorded
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    Price: ¤149.00
    by: Lynne Hare
    Reducing Variation in Manufacturing Processes
    When manufacturing variation is reduced, two good things happen. One is that the consumer’s second product experience is more like the first. This builds consumer confidence and, therefore, repeat sales. The second is fewer production line stoppages and a process flow that is more laminar, less turbulent. Both of these outcomes of Process Variation Reduction (PVR) enhance the financial bottom line.

  • Donald Jones Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Donald Jones
    Sanitation Chemical Testing - Best Practices
    Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. The objective of this presentation is to equip the participants with the basic skills and knowledge to properly perform a titration drop count test on food plant chemical cleaners and sanitizers. The participants will also be presented with a basic review of the most common single parameter titration test kits used on chemical detergents and sanitizers.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Nonresident Alien W-8 & 1042-S Compliance Update
    We will begin with the methods of identifying workers who may be non-resident aliens and proceed to the forms and methods of collecting the necessary information to determine whether back-up withholding is required. Next we will examine the rules and forms for proper depositing of back-up withholding taxes and the required reporting to the worker as well as to the IRS. Please note, beginning in 2014 the number and complexity of the forms have both increased due to the implementation of FATCA, the Foreign Accounts Tax Compliance Act.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
    Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements.

  • Donald Jones Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Donald Jones
    Environmental Cleaning
    Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.

  • Rodriguez Gonzalez Recorded
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    Price: ¤149.00
    by: Rodriguez Gonzalez
    Basics of Compliance for Food Businesses
    Adhering to rules is essential to protect your business against compliance risks. For a business whose reason of being in the market is to generate profit for its shareholders this may represent a loss in earnings and lead to deceptive practices that are considered fraud. The objective of this webinar is to analyze basic concepts around the issue of compliance using a business perspective, explore alternatives to minimize the costs of compliance and to provide some examples on how these ideas are applied in the food and beverage sector.

  • Rodriguez Gonzalez Recorded
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    Price: ¤149.00
    by: Rodriguez Gonzalez
    Metrics and Compliance
    Managing without measuring is like navigating without destination. Performance indicators are utilized by managers to track and evaluate progress towards their goals. Indicators of compliance with regulations can be easily integrated into management systems and assist with self-assessment. The goal of this webinar is to review the use of metrics to manage compliance issues and prevent conflicts before they occur. Fundamental concepts, ideas and examples will be reviewed.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    Planning for Resilience - Best Practices for Developing Reliable Disaster Recovery Plans
    The best way forward is an efficient disaster recovery solution that helps respond with speed and agility, while empowering businesses to maintain continuous operations during an outage. Such a solution also ensures availability of critical systems, reduces revenue loss, and protects brand reputation. : Emergency Planning, Business Continuity Planning and Crisis Management.

  • Stephen Alvania Recorded
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    Price: ¤149.00
    by: Stephen Alvania
    Airport Traffic Control Tower (ATCT)
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Airport Traffic Control Tower (ATCT). The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).

  • Stephen Alvania Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Air Route Traffic Control Center (ARTCC) Operations
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.

  • Stephen Alvania Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Traffic Flow Management (TFM) Operations-End to End Flight Scenario
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.

  • Reuven Rubinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Reuven Rubinson
    Accounting and Tax Procedures to Maximize your Deductions and Minimize Problems with The IRS
    Small business owners and startup companies often lack the resources to hire someone to properly set up their accounting system and their policies and procedures. They often don't know what they can and cannot deduct and, even if they do, they are unsure of the proper documentation requirements. In this webinar, we will give you a solid foundation to build your accounting system on so that you can maximize your deductions and minimize any problems with the Internal Revenue Service.

  • Anthony Goode Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Anthony Goode
    The National Shipbuilding Procurement Strategy- Changing the playing field for shipbuilding in Canada
    National Shipbuilding Procurement Strategy is a fundamental shift in the way that the Federal Government in Canada procures major ships for the Navy and the Coast Guard. Shipbuilding policy has been in a state of flux for many years as has ship procurement with many prolonged and in some cases failed procurements.

  • Anthony Goode Recorded
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    Price: ¤149.00
    by: Anthony Goode
    The Business of Defence Procurement in Canada- A Market Over
    The Defence Procurement Strategy announced in February 2014 is designed to address many of the problems that have plagued defence procurement policy for many years. It includes changes in responsibility, changes in the Industrial Regional Benefits Policy and changes in the way in which proposals are prepared and evaluated. This webinar will explain the DPS in detail and will brief participants on the major defence procurements planned over the next few years including programs for the Air Force, Navy, Army and Coast Guard.

  • Ms. Michael Redmond Recorded
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    Duration:75 Minutes
    Price: ¤149.00
    by: Ms. Michael Redmond
    ISO Standard for Business Continuity (ISO 22301)
    Learn how to create and ISO 22301program to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise.

  • Ray Kulzick Recorded
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    Price: ¤149.00
    by: Ray Kulzick
    Using Forensic Accountants Effectively in the Legal Process
    Although steadily expanding for years before Enron, Worldcom and other major frauds in the early 2000s brought the concept into the public's consciousness, the field of forensic accounting has seen rapid growth since then. This growth has steadily increased the areas where forensic accountants can be utilized far beyond just fraud investigations into almost any area where money or other "numbers" are related to the issues in a case.

  • Ray Kulzick Recorded
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    Price: ¤149.00
    by: Ray Kulzick
    Detecting Frauds in Purchasing and Payables
    Fraud and abuse losses continue to significantly impact as many as 70% of businesses, governments and non-profits annually. Purchases (from large projects to minor daily expenses) can represent as much as 60% of an organization's spending and provides those looking to steal and defraud an attractive target.

  • Miles Hutchinson Recorded
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    Price: ¤149.00
    by: Miles Hutchinson
    1099 and W-9 Update - Complying with IRS Information Reporting
    Learn the rules requiring W-9 documentation and 1099 reporting. Learn how to establish the independent contractor relationship with the right documentation. Understand the rules and keep your company in compliance. Ensure that your records will stand the scrutiny of an IRS 3rd Party Documentation and Reporting audit. Avoid the onerous penalties for noncompliance and build the best defense against the 972-CG Notice of Proposed Penalty Letter.

  • Anthony Goode Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Anthony Goode
    Controlled Goods in Canada- A primer
    The webinar will provide an introduction to the Controlled Goods Program such that the participants will understand the requirements for the program, its legislative and policy foundation as well as the process for obtaining certification and compliance with the policy. Controlled Goods Program (CGP) -a domestic industrial security program.

  • Miles Hutchinson Recorded
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    Price: ¤149.00
    by: Miles Hutchinson
    How to Write and Implement Effective Policies & Procedures
    Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of policy and procedure design, how to plan a project, including a detailed project budget, how to write clear and concise standards, how to obtain senior management approval of your policies and procedures, how to ensure compliance with those procedures, and the most efficient way to keep your processes up-to-date. He will provide practical instructions and guidance for testing the quality of your accounting procedures.

  • Rodriguez Gonzalez Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Rodriguez Gonzalez
    One practical view of HACCP Plans
    This webinar was created to review the basics of Hazard Analysis and Critical Control Points (HACCP) plans and propose ideas for business uses of this tool. Product design and profiling are a few of the areas where this tool can be applied. Because these and other applications can have economic impact in the business the idea of this webinar was to review how we can facilitate the analysis and decision making of individual situations with this tool.

  • Stephen Alvania Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Airport Traffic Control Tower (ATCT)
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Airport Traffic Control Tower (ATCT). The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).

  • Stephen Alvania Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Air Route Traffic Control Center (ARTCC) Operations
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.

  • Stephen Alvania Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Traffic Flow Management (TFM) Operations-End to End Flight Scenario
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of ATC System Command Center (ATCSCC). The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.

  • Kenneth D. Simonson Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤149.00
    by: Kenneth D. Simonson
    What's Up? (and Down): Outlook for Construction Segments, Materials and Labor
    This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.

  • Kenneth D. Simonson Recorded
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    Price: ¤149.00
    by: Kenneth D. Simonson
    Construction Shortages Ahead: Skilled Labor, Skilled Manager
    This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.

  • Miles Hutchinson Recorded
    View Anytime
    Duration:60 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    How to Analyze Financial Statements
    Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.

  • Anthony Kioussis Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Anthony Kioussis
    The Value of Hourly Cost Maintenance Programs
    Hourly Cost Maintenance Programs (HCMP) were originally introduced by the engine and airframe OEMs to demonstrate their confidence in the cost to maintain their product. Today, these Programs have become a near staple for many aircraft, to the point where the value for many assets is negatively impacted absent HCMP coverage.

  • Anthony Goode Recorded
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    Price: ¤149.00
    by: Anthony Goode
    Canada's Defence Budget Crisis- Impact of recent Defense Budget Cuts on The Canadian Armed Forces- Opportunities for Industry
    Even though the present government committed to increasing defence spending, the reality of reducing the deficit incurred during the financial crisis has affected every part of government including National Defence. In order to understand the impact of the various spending reduction exercises on DND, it is essential to be aware of the background to the current budget situation, which offers some key insights.

  • Brian Perlberg Recorded
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    Price: ¤149.00
    by: Brian Perlberg
    Contract Killer Clauses in Construction: And How to Neutralize Them
    The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.

  • John E Lincoln Recorded
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    Price: ¤189.00
    by: John E Lincoln
    The Master Validation Plan - The Unwritten Requirements
    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

  • Heath Rushing Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Heath Rushing
    Quality by Design: Establishing a Systematic Approach to Pharmaceutical development
    This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

  • David R Dills Recorded
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    Price: ¤189.00
    by: David R Dills
    FDA's Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List
    Device firms, establishments or facilities that are involved in the production and distribution of medical devices intended for use in the U.S are required to register annually. Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices.

  • Dr. Ludwig Huber Recorded
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    Price: ¤189.00
    by: Dr. Ludwig Huber
    FDA Compliant HPLC Qualification and Performance Testing
    High Performance Liquid Chromatography is the most frequently used analytical tool for pharmaceutical and API testing laboratories. FDA and international agencies require HPLC equipment to be calibrated, qualified and tested to ensure accurate and reliable analytical results. Even though this is well known since long time, laboratories are unsure on what exactly should be tested initially and on an on-going basis.

  • Steven S. Kuwahara Recorded
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    Duration:75 Minutes
    Price: ¤189.00
    by: Steven S. Kuwahara
    GMP Perspectives on Working with Contracting Laboratories
    When working with contract testing laboratories, clients must remember that the responsibility for compliance with the GMP or the GLP ultimately lies with the product sponsor. Even if the contract assignes the responsibility to the contract laboratory, the responsibility for assuring compliance lies with the client. Neither can the contract laboratory assume that the client has complied with their responsibilities.

  • Melinda Allen Recorded
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    Duration:75 Minutes
    Price: ¤189.00
    by: Melinda Allen
    Cleaning and Sanitation Training for Food Processors
    We will cover several topics of value to food manufacturing sanitation team members. We will begin with a conceptual understanding of cleaning vs. sanitation.

  • Steven S. Kuwahara Recorded
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    Price: ¤189.00
    by: Steven S. Kuwahara
    Auditing Analytical Laboratories for FDA Compliance
    Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requirements depending upon the type of testing that is being conducted. In many cases, the laboratory itself may not understand what regulations apply to the work that is being conducted.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Compiling the Design History File, and Technical File, Design Dossier
    This webinar will examine both the FDA and MDD regulatory expectations for the respective DHF and TF / DD. It will discuss the major sections of both, common elements and differences, what must be included and what should be included, and how the information should be compiled and presented.

  • David R Dills Recorded
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    Price: ¤189.00
    by: David R Dills
    FDA's 2011 Draft Guidance on Financial Disclosure by Clinical Investigators
    This webinar will provide an overview and guidance to firms that are either going through or preparing to go through clinical trials and working with clinical investigators.

  • Robert J. Russell Recorded
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    Price: ¤189.00
    by: Robert J. Russell
    The European Clinical Trial Directive (EUCTD)
    The course also covers recent updates on EU GCP associated with the Directive, the highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators.

  • Dr. Ludwig Huber Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Dr. Ludwig Huber
    Quality by Design (QbD) for Development and Validation of Analytical Methods
    Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine.

  • Thomas E. Colonna Recorded
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    Duration:2 Hours
    Price: ¤189.00
    by: Thomas E. Colonna
    FDA Regulation of In Vitro Diagnostics
    In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.

  • Dan OLeary Recorded
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    Price: ¤189.00
    by: Dan OLeary
    Statistical Concepts of Process Validation
    The FDA QSR requires device manufacturers to validate processes when the manufacturer cannot "fully verify the output". The manufacturer must validate these processes with a "high degree of assurance".

  • John E Lincoln Recorded
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    Duration:75 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Change Control - Key to Successful cGMP Compliance
    There is a continuing pervasive public perception that the FDA has been ineffective in protecting the public. Recent news events in foods, drugs, and devices seem to support this perception. The "tougher" FDA is determined to change that perception. Industry must be prepared to adapt, and recognize that such adaptation will actually work to their long-term benefit. This webinar will discuss and evaluate the effects that this call for change has on a company and its change control policies and systems.

  • David R Dills Recorded
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    Price: ¤189.00
    by: David R Dills
    How to Manage a Medical Device Recall Efficiently and Effectively
    This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA's involvement.

  • Albert A. Ghignone Recorded
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    Price: ¤189.00
    by: Albert A. Ghignone
    The FDA Drug Development Process: GLP, GMP and GCP Regulations
    This webinar provides an overview of the FDA's Drug Development Process. This webinar also includes the major FDA regulations involved in the Drug Development Process - the GLP, GMP and GCP regulations.

  • Elisa Harvey Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Elisa Harvey
    Understanding Combination Products, Requests for Designation and Product Jurisdiction
    This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA’s Office of Combination Products.

  • Elisa Harvey Recorded
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    Price: ¤189.00
    by: Elisa Harvey
    Using the Pre-Submission Process to Your Best Advantage
    This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Foreign Bodies in Foods - Effective Techniques for Prevention, Control and Detection
    Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.

  • Rotimi Toki Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Rotimi Toki
    Food Labelling: A Practical Guide for Unambiguous Labelling Information & Compliance with Regulatory Requirements
    Attend this webinar to have a clear understanding of what information should be on a label.The training session will dwell extensively on the ten legally bound things on the list of information which labelling laws say must be included on most foods. Participants would be shown with practical examples how to calculate Quantitative Ingredient Declaration (QUID), when to apply it and when it is inappropriate for use.

  • Robert J. Russell Recorded
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    Price: ¤189.00
    by: Robert J. Russell
    EU Pharmacovigilance Directive and Regulations
    New Legislation & Guidance for Pharmacovigilance will apply in the European Union (EU) beginning July 2012. To assist in its implementation with sponsors, applicants and license holders, a series of Guidance Documents is being written, which will replace the current set of Volume 9A of the Rules Governing Medicinal Products in the EU.

  • Robert Kunka Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Robert Kunka
    Developing an Efficient Relationship with FDA
    Some pharmaceutical companies do not have the experience in the regulatory area which includes knowledge of the process, needs, and results necessary for a company to be productive at the regulatory agency. Just as a couple dances together, the pharmaceutical company "dances" with the regulatory agency. Neither of the partners wants to step on the feet of the other.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Device Changes, FDA Changes, and the 510(k)
    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

  • David R Dills Recorded
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    Price: ¤189.00
    by: David R Dills
    Maintaining an Effective CAPA Program and Using Risk Assessment Tools: Current Trends
    CAPA programs are critical for any manufacturer. FDA considers your program the immune system for your site business unit and determines how healthy or unhealthy you are.

  • Dan OLeary Recorded
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    Price: ¤189.00
    by: Dan OLeary
    Device Corrections and Removals
    When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA?

  • Steven S. Kuwahara Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Steven S. Kuwahara
    GMP Expectations for Products Used in Early Phase IND Studies
    FDA issued a guidance document covering GMP requirements for Phase 1 products. These guidelines remove some of the problems that are encountered with early phase products and are in addition to those that cover the CMC sections for IND submissions at Phase 1.

  • Robert E. Davis Recorded
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    Duration:75 Minutes
    Price: ¤149.00
    by: Robert E. Davis
    IT Auditing - Principles and Practices (2nd Edition)
    There exists apparent financial auditor (FA) and IT auditor responsibility overlaps. One reason this interrelationship exists is because, when planning audits, the FA and IT auditor evaluate manual as well as automated processing.

  • Teri C. Soli Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Teri C. Soli
    Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
    Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

  • Dan OLeary Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Dan OLeary
    Regulatory Requirements for Medical Device Calibration Programs
    Calibration is an essential component of every Quality Management System (QMS). An effective system includes more than just management of stickers on equipment. This presentation will give you the background need to understand the requirements and effectively implement.

  • Dan OLeary Recorded
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    Duration:75 Minutes
    Price: ¤189.00
    by: Dan OLeary
    Acceptance Sampling by Variables
    Many companies use attribute sampling plans at incoming, in-process, and final inspection. The common approach uses ANSI/ASQ Z1.4. There is an alternate, however, that may reduce cost. Sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes.

  • Randy Goodden Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Randy Goodden
    Preventing Product Liability - Key Areas Manufactures Need to Control
    Protecting the manufacturing corporation from product liability lawsuits isn't just about product design and engineering, it involves the activities in a number of different management areas from the CEO down to the lowest levels of management. In this segment we will identify each of those individual areas, what could be going wrong and unnoticed, and how to prevent such exposure to liability.

  • Randy Goodden Recorded
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    Price: ¤149.00
    by: Randy Goodden
    Preventing Recalls & Product Liability in New Product Development
    Some products in specific industries, such as consumer products, automotive, food and pharmaceutical have to be designed and manufactured in compliance to that industry's regulatory requirements, which is wrongly viewed as the only safety requirement the manufacturer needs to really focus on in design, but such regulatory requirements offer no guarantee or assurance that the product is then 'safe'.

  • Robert J. Russell Recorded
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    Duration:60 Minutes
    Price: ¤189.00
    by: Robert J. Russell
    Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
    This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together. This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers developing these arrangements together.

  • Karl Leinsing Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Karl Leinsing
    Medical Device Product Development Process
    We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.

  • Anne Tomalin Recorded
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    Price: ¤189.00
    by: Anne Tomalin
    Conducting Observational Studies in US, Canada and Europe
    This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.

  • Anne Tomalin Recorded
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    Price: ¤189.00
    by: Anne Tomalin
    Clinical Trials in US, Europe and Canada
    This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.

  • Anne Tomalin Recorded
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    Price: ¤189.00
    by: Anne Tomalin
    International Regulatory Cooperation Among Agencies
    This presentation will review what we know of how regulatory agencies are working together internationally to share best practices in reviewing drugs. It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made.

  • Casper Uldriks Recorded
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    Price: ¤189.00
    by: Casper Uldriks
    Managing FDA 483s: Before, During and After the Inspections
    The FDA Form 483 represents an inspectional record of objectionable conditions observed by the FDA investigator during an inspection of a manufacturing establishment. The inspection will cover a certain set of regulations that apply to the particular manufacturer's operations. Products regulated by FDA have different manufacturing, records and reporting regulations.

  • Casper Uldriks Recorded
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    Price: ¤189.00
    by: Casper Uldriks
    Rational Predictions for FDA inspections
    The webinar covers factors considered by FDA before, during and after an inspection that can be used to predict your inspectional vulnerability. Once you know some key points, you will see that FDA's approach to inspections follows well-established procedures and risk criteria that enables FDA to characterize your firm's compliance. Usually the only way FDA will let you know about your profile is when an official action is indicated. That is not a good thing. Otherwise, you hear very little and even then, you may wait a long time. The cloud of doubt can plague a firm for months.

  • Karen Greene Recorded
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    Price: ¤189.00
    by: Karen Greene
    Sterile Medical Packaging Design – 7 Essentials
    Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.

  • Jeff Kasoff Recorded
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    Price: ¤189.00
    by: Jeff Kasoff
    Bulletproof Supplier Management Program
    A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA cannot regulate component suppliers, it is imperative that your company's purchasing and supplier control requirements provide the assurance that only acceptable components are used to manufacture finished devices.

  • Jeff Kasoff Recorded
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    Price: ¤189.00
    by: Jeff Kasoff
    Complaint Handling in Compliance with FDA and ISO Regulations
    Negative customer feedback about a medical device's performance or safety is a strong indicator of whether a firm's manufacturing process is in control. This feedback is therefore subject to many requirements in both the QSR and ISO 13485. Failure to follow up on complaints about medical devices is among the most frequently cited observations on FDA-483s.

  • Jeff Kasoff Recorded
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    Price: ¤189.00
    by: Jeff Kasoff
    A CAPA Primer - Elements of a CAPA Program
    A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program.

  • Jeff Kasoff Recorded
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    Price: ¤189.00
    by: Jeff Kasoff
    FDA Inspections – Do's and Don'ts
    Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave? The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!

  • Lynne Hare Recorded
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    Price: ¤149.00
    by: Lynne Hare
    The Strategy of Experimentation
    Research resources are too scarce to be squandered going down blind alleys and coming up empty handed at project end. We can no longer afford to play hunches or to rely on so called experts, whose opinions all differ, to guide research. Nor can we rely on the gross inefficiencies of old-fashioned one-factor-at-a-time experimentation to guide decisions. Instead, R&D must proceed systematically and with a goal of using unbiased data to guide decisions, following an overall strategy guided by statistical thinking and the scientific method.

  • Donald Jones Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Donald Jones
    Chemical Safety for Sanitation Workers
    Companies must provide effective chemical safety training for all employees including managers, supervisors, operators and temporary workers. The objective of this presentation is to equip the participants with the basic skills and knowledge to assess chemical hazards in their workplace. The participants will also be presented with basic controls for working safely with chemical detergents and sanitizers used in food processing plants.

  • Kenneth D. Simonson Recorded
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    Price: ¤149.00
    by: Kenneth D. Simonson
    What's Up? (and Down): Outlook for Construction Segments, Materials and Labor
    This webinar provides a detailed look at recent trends and outlook for construction spending, materials costs and employment, nationally and by state. Rather than treating construction as a single industry or a simple split between residential and nonresidential, the webinar delves into the sharply differing trends and future drivers for single- and multifamily residential construction, 10 categories of private nonresidential construction, and the leading public categories-highway & street and educational, both K-12 and higher.

  • Fred Vacelet Recorded
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    Price: ¤149.00
    by: Fred Vacelet
    Operational Risk - Beyond Regulatory Constraints
    In financial institution, operational risk has been considered as minor compared to credit risk and market risk. Moreover, Operational Risk is too difficult to grasp for bankers. Therefore operational risk management is often considered as a regulatory constraint or as an imprecise practice rather than a science, and it is often hijacked by political necessities, or can turn into insignificant exercises aimed at predicting small losses or improving efficiency without consideration for high-impact risks.

  • Stephen Alvania Recorded
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    Price: ¤149.00
    by: Stephen Alvania
    ATC Radar Approach Control (TRACON)
    Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Air Route Traffic Control Center (ARTCC) Operations
    This webinar, one in a series of ATC topics, addresses the operational environment and functioning of the Air Route Traffic Control Center (ARTCC). The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.

  • Erin Hallenberg Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Erin Hallenberg
    Evaporation Ponds: a Permitting Labyrinthine
    Evaporation Ponds are used throughout the nation for various purposes. The Oil & Gas industry uses this methodology to separate out hydrocarbons and dispose of the large amounts of process water from operations. With the purpose of evaporation in mine, even small operations are finding out they can be classified as Major Source. Several other types of permits and plans may also apply to "evap ponds".

  • Anthony Goode Recorded
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    Price: ¤149.00
    by: Anthony Goode
    Controlled Goods in Canada - A primer
    The webinar will provide an introduction to the Controlled Goods Program such that the participants will understand the requirements for the program, its legislative and policy foundation as well as the process for obtaining certification and compliance with the policy. Controlled Goods Program (CGP) -a domestic industrial security program.

  • Anthony Goode Recorded
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    Duration:75 Minutes
    Price: ¤149.00
    by: Anthony Goode
    Industrial Technical Benefits- Canada's New Approach to Offsets for Defence Procurement
    Industrial Technical Benefits- Canada's new approach to offsets for defence procurement: As part of the recently announced Defence Procurement Strategy, the Canadian Government has introduced a new industrial benefits policy that is designed to leverage purchases of defence equipment to create jobs and economic growth in Canada. Companies pursuing defence procurement opportunities in Canada will be required to submit value propositions, include key industrial capabilities (KIC) in their proposal and submit detailed industrial and technological benefits (ITB) plans with their proposals that will then be rated by the Government.

  • Donald Jones Recorded
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    Duration:75 Minutes
    Price: ¤149.00
    by: Donald Jones
    Environmental Cleaning
    Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    Building a Sustainable Vendor Qualification Program
    Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    Building a Validation Program From Top to Bottom
    Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    FDA Inspections – Do's and Don'ts
    Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

  • Dr. Michael Forstner Recorded
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    Price: ¤189.00
    by: Dr. Michael Forstner
    Drug Safety Risk Management Planning
    Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.

  • Louis Angelucci Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Louis Angelucci
    Establishment of Quality Systems
    Quality Systems are a fundamental aspect of all pharmaceutical and medical device firms. They are an expectation and regulated requirement. Exactly what constitutes a quality system is different depending on the firm and the culture. Defining quality systems and then tracing them properly back to the FDA definitions is paramount for compliance and regulatory inspection preparedness.

  • Louis Angelucci Recorded
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    Duration:60 Minutes
    Price: ¤189.00
    by: Louis Angelucci
    Introduction to Risk Assessment
    Risk Assessment is a fundamental expectation in the regulated industries of pharmaceutical and medical devices. Performing risk assessments can be interpretive and needs to be well thought out in order to rationalize and substantiate conclusions drawn. With proper use it is a good model and will save in terms of dollars and schedule when properly applied. Risk Assessment is a regulatory expectation that should be taught and emphasized at all levels of a going concern.

  • Denise Cicchella Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Denise Cicchella
    Foreign Corrupt Practices Act - Audits Role
    The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.

  • Stuart Gardner Recorded
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    Price: ¤149.00
    by: Stuart Gardner
    Project Management - Auditing Problem Projects
    Every project undertaken is not a guaranteed success; there are many things that can and do go wrong. Overly optimistic budgets or underfunded projects can result in shortcuts or unrealistic pressures on those working on the project. Staff or resources lacking the skills to work on the project see the assignment as a fast track to promotion and may not be willing to admit they can not handle the project, projects escalated to be done quickly may result in shoddy workmanship, resources pulling on time constraints can stretch employees to thin, opposition may even exist that is looking to have the project fail - yes sabotage is more common than many will admit to.

  • Stuart Gardner Recorded
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    Price: ¤149.00
    by: Stuart Gardner
    Auditing Third Party Agreements - Common Pitfalls from IT to Construction
    hird party agreements cover everything from cleaning to the provision and operation of strategic information technology systems. From the simplest of services to the most complex, such agreements can bring significant benefits including economies, more effective services than could be delivered in house and expert knowledge and skills. However, this comes at a price: strategic risks and new uncertainties can hide within such agreements.

  • Kenneth D. Simonson Recorded
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    Duration:60 Minutes
    Price: ¤149.00
    by: Kenneth D. Simonson
    Construction is Building, but Where will the Workers Come From?
    The webinar begins with a brief review of how total construction spending and its major components-private residential, private nonresidential and public construction-fared during the industry’s long slump from 2006 to 2011, and how far each component has recovered to date.

  • Leo Lagrotte Recorded
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    Price: ¤189.00
    by: Leo Lagrotte
    Complaint Handling for Medical Device Manufacturers
    As an experienced FDA medical device investigator, approximately 90% of all FDA 483 I've issued contained inspectional observations that included firm's inability to establish and implement Complaint Handling procedures in compliance with 21 CFR 820, or failed to follow their own established procedures. Either way can get a firm into sufficient Warning Letter territory.

  • Michael Brodsky Recorded
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    Price: ¤189.00
    by: Michael Brodsky
    Laboratory Accreditation: Getting there is just the beginning
    Many laboratories regard Quality Assurance, Quality Assessment and Quality Control as independent activities, others use the terms interchangeably, e.g. QA/QC. This demonstrates a lack of appreciation of the differences between Assurance, Assessment and Control, as well as the interrelationships, particularly between QA and QC. This has created confusion in the minds of many analysts with respect to understanding how QA and QC play separate, but related roles for achieving Quality Assurance in a Quality Management System (QMS). QMS is the catch phrase for accreditation and is the backbone of ISO/IEC Standard 17025:2005.

  • Michael Brodsky Recorded
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    Price: ¤189.00
    by: Michael Brodsky
    An Environmental Microbiologist's View on Estimation of Uncertainty of Measurement
    Many microbiology laboratories are confused about what MU is, how to calculate it and how to apply it. We will discuss what is needed to meet the accreditation requirement for MU, including, what data to collect and how to analyze it. Also a practical step by step approach to data compilation specifically applicable to microbiology will be discussed.

  • Michael Brodsky Recorded
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    Price: ¤149.00
    by: Michael Brodsky
    Verification or Validation of Methods in Food Microbiology
    Although method validation and method verification are related terms, they have very different analytical and statistical requirements particularly for compliance with ISO/IEC 17025:2005. Unfortunately, the terms are often incorrectly used interchangeably, resulting in confusion and the application of inappropriate or inadequate analytical evaluations.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Gluten - Free Product: How to Prove & Display It Correctly
    The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten - free products are a necessity. To help assure customer confidence, the FDA issued a final rule in August 5, 2014 that defines gluten - free claims across the food industry. To enforce the final rule FDA may use its full range of routine post- market monitoring activities, including periodic inspections of manufacturer's facilities, food label reviews and gluten analyses of food samples.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Proven Cleaning and Sanitation Techniques for Food Processors
    Cleaning and sanitation programme are essential to control the hazards of microbiological and physical contamination of foods in the foodservice and food manufacturing facilities. To ensure that a facility and equipment are clean, sanitised and suitable for their intended use, management of the food business must draw up and operate a written sanitation programme and suitable cleaning procedure for all equipment surfaces and structures within the facility.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Ready- to-eat Foods: Pathogens of Concern and Intervention Controls
    Consumer demand for minimally processed products with a longer shelf-life has resulted in the mass production and distribution of chilled convenience RTE foods. However, RTE foods remain a significant vehicle for foodborne pathogens such as Listeria monocytogenes. The challenges are enormous because production of RTE foods frequently involves extensive processing and packaging. Therefore, this webinar is designed to review current knowledge on the pathogens of concern, sources and intervention controls.

  • Thomas E. Colonna Recorded
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    Price: ¤189.00
    by: Thomas E. Colonna
    FDA Regulation of Combination Products
    A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

  • Thomas E. Colonna Recorded
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    Price: ¤189.00
    by: Thomas E. Colonna
    FDA Regulation of Dietary Supplements
    FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

  • John N. Zorich Recorded
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    Price: ¤189.00
    by: John N. Zorich
    Better Alternatives to Sampling Plans
    The webinar begins with an examination of ISO and FDA regulations and guidelines regarding the use of statistics, especially in regards to Sampling Plans. The pros and cons of the 2 most widely used sampling plans (ANSI Z1.4, and Squeglia's C=0) are examined in detail, focusing especially on the weaknesses of such plans in regards to meeting regulatory requirements. Real-world examples are provided for how using such sampling plans leads to production of non-conforming product.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Introduction to SPC (Statistical Process Control)
    Manufacturing involves an attempt to produce items that as closely as possible meet design specifications (e.g., size, strength, etc.). However, all production processes exhibit variation - that is, no two items are identical. What method can we use to reduce such variation? The classic and still most widely used method is called SPC or "statistical process control".

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Statistical Analysis of Gages
    The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios". Several of the standard methods for analyzing measurement variation are then described and explained, as derived from AIAG's Measurement System Analysis reference book. The methods include: Gage R&R (ANOVA method, for 3 gages, 3 persons, 3 replicates, and 10 parts), Gage Correlation (for 3 gages), Gage Linearity, and Gage Bias.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Confidence-Reliability Calculations and Statistically Valid Sample Sizes
    The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Normality Tests and Transformations
    Normality Tests and normality transformations are a combination of graphical and numerical methods that have been in use for many decades. These methods are essential to apply whenever a statistical test or method is used whose fundamental assumption is that the inputted data is normally distributed.

  • Leo Lagrotte Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Leo Lagrotte
    Medical Devices and Radiation-Emitting Products: FDA Requirements
    As an experienced FDA medical device investigator, at one time or another many firms have failed to incorporate the requirements of 21 CFR 1002 and 21 CFR 1040 when designing and planning to file premarket clearance documents with FDA.

  • Leo Lagrotte Recorded
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    Price: ¤189.00
    by: Leo Lagrotte
    What does FDA require for Medical Devices Manufacturers to Do When Filing an Adverse Event Report (MDR)
    As an experienced FDA medical device investigator, many firms have failed to fully incorporate the requirements of 21 CFR 803 when establishing and implementing their reporting procedures.

  • Hannes Wagner Recorded
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    Price: ¤149.00
    by: Hannes Wagner
    Gold in Plant Tailings - Prevention and Recovery
    During 19 years as mineralogist in the mineralogical Laboratory of Anglovaal Limited the speaker was responsible, among other duties, for assisting metallurgical plants with recovery problems. He was able to assist plants that were recovering gold from Paleo placer deposits (Witwatersrand) and Greenstone domains (Barberton Mountain Land). This talk presents the seven most common causes encountered and solutions for most.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    Developing a Cyber Incident Response Program
    The best way forward is an efficient Incident Response Program that allows an organization to respond with speed and agility, while empowering businesses to maintain continuous operations. Such a solution also reduces revenue loss, reduces fines and lawsuits and protects brand reputation.

  • Miles Hutchinson Recorded
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    Price: ¤149.00
    by: Miles Hutchinson
    How to Analyze Financial Statements
    Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Mastering the Power of Sensitivity Tools in Financial Modeling
    Miles Hutchinson, will show you how to unlock the power of scroll bars and spinners, goal seek, one and two-input data tables and scenario manager in your models. He will provide you with samples of the tools demonstrated during the webinar along with complete instructions for creating and using each of these tools.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    How to Design and Implement Outstanding KPI Performance Dashboards
    Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Airport Traffic Control Tower (ATCT)
    The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Terminal Radar Approach Control (TRACON)
    Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Air Route Traffic Control Center (ARTCC) Operations
    The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Stephen Alvania
    Traffic Flow Management (TFM) Operations-End to End Flight Scenario
    The topic starts with the communication system design that delivers the single ATCSCC facility with the radar and flight data from the entire National Airspace System (NAS) for real time processing and assessment. There is then a discussion of the various goals, strategies, and techniques the ATCSCC employs to manage and resolve areas of significant traffic congestion and delay.

  • Joseph Habarta Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Joseph Habarta
    Pharma Contract Manufacturing: Managing Quality and Technical Agreements
    The identification and arrangement with a contract service provider (CSP) for the manufacture or testing of an early or late stage pharma product provides many opportunities as well as pitfalls. The reasons for turning to a CSP frequently are due to resources, either capital or monetary, headcount or level of expertise, technical capabilities or most commonly TIME. Meeting timelines and doing it right in the development and realization of a pharma product can be at loggerheads with one and another and turning to a CSP can be the answer.

  • Steven Walfish Recorded
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    Price: ¤189.00
    by: Steven Walfish
    Using Statistics to Determine Sample Size
    This webinar covers the statistical methods used to calculate sample sizes for both attribute and variables data. Methods for collecting the sample will be covered. Every sampling plan has risks. This webinar covers how to calculate Type I and Type II errors. A discussion of how the FDA views sampling plans, especially for validation and acceptance activities. Sample size to ensure a certain level of process capability will be covered.

  • David R Dills Recorded
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    Price: ¤189.00
    by: David R Dills
    Complaint Handling and Management: From Receipt to Trending
    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

  • David R Dills Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: David R Dills
    Bullet Proof 510(k) – Latest FDA Changes to the Process
    There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

  • David R Dills Recorded
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    Duration:3 Hours
    Price: ¤189.00
    by: David R Dills
    Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
    What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

  • David R Dills Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: David R Dills
    Conducting Successful Product Complaint Investigations
    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

  • David R Dills Recorded
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    Duration:90 Minutes
    Price: ¤139.00
    by: David R Dills
    Establish and Maintain an Effective Supplier Qualification Program
    FDA considers the supplier as an extension of your operation. You are liable for supplier’s conduct (as it relates to your product). FDA will deal with your company in case of product failure, especially as related to end user or patient safety concerns.

  • Herman Bozenhardt Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Herman Bozenhardt
    Biological Facility Design for Compliance
    The field of biological facility design has been one of the most evolving engineering practices over the last 30 years. In the 1980s most biological facilities were modeled after generations of antibiotic production. These were large and suffered with significant bioburden problems.

  • Lynne Hare Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Lynne Hare
    Reducing Variation in Manufacturing Processes
    When manufacturing variation is reduced, two good things happen. One is that the consumer’s second product experience is more like the first. This builds consumer confidence and, therefore, repeat sales. The second is fewer production line stoppages and a process flow that is more laminar, less turbulent. Both of these outcomes of Process Variation Reduction (PVR) enhance the financial bottom line.

  • Anna Longwell Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Anna Longwell
    A second look at 510(k) changes
    The topic is 510(k) changes, a topic that is still producing more than its share of 483's and warning letters. In general, FDA does not return filings because the change described in them is not sufficiently "significant", and only rarely suggests that the traditional 510(k) should at least be scaled down to a special 510(k).

  • Adriaan Fruijtier Recorded
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    Price: ¤189.00
    by: Adriaan Fruijtier
    The New Clinical Trial Regulation
    On 16 April 2014 the new Regulation EU No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC was adopted, and published in the Official Journal on 27 May 2014 (the "Clinical Trials Regulation").

  • Ricardo Valls Recorded
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    Price: ¤189.00
    by: Ricardo Valls
    Lineament analysis- The Modern Way to Look for Ore Deposits
    We will introduce you to an effective and affordable methodology that identifies prospective targets which are related to, or controlled by tectonic structures. Even over new areas with limited or nonexistent geological information we are able to help you concentrate your exploration efforts to keep your budget in the black.

  • John E Lincoln Recorded
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    Price: ¤189.00
    by: John E Lincoln
    "Zero Defects" and the cGMPs - Pros and Cons
    U. S. FDA-regulated companies are responsible for understanding current Good Manufacturing Practices (CGMPs) as defined in the Code of Federal Regulations ( 21 CFR Part 111, 210/211, and 820).

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Avoid Warning Letters in View of the U.S. FDA's Stated Goal
    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies.

  • Randy Goodden Recorded
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    Price: ¤149.00
    by: Randy Goodden
    Preventing Recalls & Product Liability in New Product Development
    The largest cause of Product Liability Lawsuits and Recalls comes from "Defects in Design". The product was defective right from the start, but no one caught it in time.

  • John E Lincoln Recorded
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    Price: ¤189.00
    by: John E Lincoln
    CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
    Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

  • John E Lincoln Recorded
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    Duration:60 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Design Controls - Requirements for Medical Device Developers
    This webinar will discuss the 9 required elements of a Design Control System. It will consider different methods of implementation, and expectations of the U.S. FDA, proven by documentation.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John E Lincoln
    DHF, DMR, DHR, Technical File and Design Dossier - Key Requirements and Future Directions
    It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤147.00
    by: John E Lincoln
    Developing the Master V&V Plan to Meet U.S. FDA, ISO 13485 and 14971 Requirements
    FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. One major failing is lack of sufficient or targeted risk-based company-wide V&V planning.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John E Lincoln
    Device Changes, FDA Changes, and the 510(k)
    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

  • Miles Hutchinson Recorded
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    Price: ¤149.00
    by: Miles Hutchinson
    Complying with FATCA - the Foreign Accounts Tax Compliance Act
    Miles Hutchinson, experienced CPA and financial analyst, will discuss the basic principles of FATCA, the affected businesses and individuals, the new and revised forms to effect compliance and provide you with simplifying charts and tables to help you determine your steps to full compliance. He will provide practical instructions and guidance for applying FATCA and will identify the key issues that will help you avoid potential penalties for noncompliance.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    Introduction to Sales and Use Taxation
    Join us and you can begin to develop a solid plan to move your company toward sales and use tax compliance. Experienced CPA and businessman, Miles Hutchinson, will review the basics of sales and use taxation with you and answer your questions. He will discuss legal developments in the area of taxation of internet sales. You will receive practical guidance to avoid penalties due to the ever increasing instances of audits by state taxing authorities.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    1099 and W-9 Update - Complying with IRS Information Reporting
    What are the rules regarding paying and IRS reporting on Independent Contractors? How do I avoid the IRS CP-2100 (B-Notices)? What if my vendor claims exemption; must I obtain a W-9 anyway? What are the best practices? How can I minimize risk of improper exemption claims by my vendors? Get the answers to these and related questions to reduce your risk of huge penalties from the IRS.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤138.00
    by: Miles Hutchinson
    Introduction to Payroll Law
    Are you responsible for payroll or employer tax withholding compliance? Or maybe you were recently hired or promoted into the payroll department. During your indoctrination you are surprised at all the interesting things to do and how important this role is to the success of the company.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Miles Hutchinson
    TIN Matching to Reduce Your B-Notices and Eliminate Proposed Penalties
    Learn the best practices for eliminating 1099 error notices from the IRS. Discover the power of the TIN Matching system. Learn how to handle the CP-2100 notices from Uncle Sam and avoid the fines & penalties for failure to timely comply with the B-Notice requirements. Understand the difference between and 1st and 2nd B-Notice and the related differences in required vendor responses. Be sure you institute and stop Backup Withholding when required.

  • Jerry Lanese Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Jerry Lanese
    Analytical Method Validation
    An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  • Roger Nakata Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Roger Nakata
    Understanding Next Gen (FAA New Technology)
    FAA Definition: NextGen is the evolution of the NAS to a more advance state, which makes better use of technology and design to more efficiently meet transportation needs.

  • Jerry Dalfors Recorded
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    Price: ¤189.00
    by: Jerry Dalfors
    Process Validation - Statistical Process Control
    Process knowledge and understanding is the basis for establishing an approach to process control and related instruction sets in the Batch Record for each critical step of the process operation and the overall process results based on statistical database for each batch of that product code. Strategies for process control and operator activities can be designed to reduce variation, adjust for variation during manufacturing and reduced possibility for operator error, as well as an overall blend to manage critical process parameters (CPPs) as well as the original process limits which typically change after the initial validation as well as the trend analysis for each critical step of the process.

  • Jerry Dalfors Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Jerry Dalfors
    Lyophilization Technology
    Lyophilization cycles consist of three phases: Freezing, primary drying, and secondary drying. Conditions in the dryer are varied through the cycle to ensure that the resulting product has the desired physical and chemical properties and that the required stability and sterility is achieved and maintained.

  • Jan Gates Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Jan Gates
    Impulse Sealing: Trials and Tribulations
    Manual and semi-manual impulse sealing is inherently safe on the production line without continuous heat on the jaws. The sealing can be difficult to validate when factors, beside humans, are not understood and controlled properly. Jan takes you through various factors she has found to effect impulse sealers and to the newer technology that reduces the issues.

  • Karl Leinsing Recorded
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    Duration:60 Minutes
    Price: ¤189.00
    by: Karl Leinsing
    Medical Device Product Development Process
    We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process.

  • John Ryan Recorded
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    Price: ¤149.00
    by: John Ryan
    Standardizing Transportation Procedures to Control Food Safety and Quality
    The course includes activities to help trainees develop a general plan and procedures to standardize and control food quality and safety transportation processes. For food shippers, carriers and receivers, standardization or upgrade to current practices is critical. For buyers, knowing how to establish standards for your food transporters sets the stage for required supply chain controls.

  • Roger Bezdek Recorded
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    Duration:75 Minutes
    Price: ¤149.00
    by: Roger Bezdek
    The Social Cost of Carbon: The EPA's Stealth Imposition of a Carbon Tax That Will Make Everything More Expensive and Less Efficient
    The Social Cost of Carbon (SCC) is being used by EPA, NHSTA, and other Federal regulatory agencies to impose a large de-facto carbon tax on the U.S. economy - a tax that the U.S. Congress would never pass.

  • Adriaan Fruijtier Recorded
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    Price: ¤189.00
    by: Adriaan Fruijtier
    Regulatory Aspects of Advanced Therapy Medicinal Products in the EU
    Advanced therapy medicinal products are human cells and tissues or products with a genetic mode of action; they generate huge expectations but are also associated to new significant threats including tumorigenicity, cell (de)differentiation, and patient integration.

  • Adriaan Fruijtier Recorded
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    Price: ¤189.00
    by: Adriaan Fruijtier
    Scientific Advice in the EU
    Scientific advice helps the company to make sure that it performs the appropriate tests and studies, so that no major objections regarding the design of the tests are likely to be raised during evaluation of the marketing-authorization application. Such major objections can significantly delay the marketing of a product, and, in certain cases, may result in refusal of the marketing authorization. Following advice from the Regulatory Authorities increases the probability of a positive outcome.

  • Adriaan Fruijtier Recorded
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    Price: ¤121.00
    by: Adriaan Fruijtier
    Product Information in the EU
    In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.

  • Jerry Lanese Recorded
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    Price: ¤189.00
    by: Jerry Lanese
    cGMPs in the Quality Control Laboratory
    Since the mid 1980s, the Quality Control Lab oratory has been a prime target for FDA investigators during site inspections. Since that time, investigators have made many 483 observations. Unless the firm reacts very aggressively, the 483 observations will be escalated to Warning Letter citations.

  • Rotimi Toki Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Rotimi Toki
    HACCP in Foodservice Establishment - Practical Design & Implementation
    Primary responsibility for food safety lies with the business operator. The increasing expectations from consumers' couple with the demand to detect hazards and sources of foodborne illness, together with implementation of FSMA have the potential of raising the bar in terms of food safety management. HACCP system allows you to predict risks to food safety and prevent them before they happen.

  • John Ryan Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: John Ryan
    FSMA Impact to the Transportation of Perishables
    This webinar is designed to help you understand how the new rules for the sanitary transportation of human and animal foods will impact your logistics operations and to provide you with some of the tools needed to meet new regulations and customer demands.

  • John N. Zorich Recorded
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    Price: ¤189.00
    by: John N. Zorich
    Understanding, Calculating, and Using Statistical Power
    Statistical power is an indicator of the ability of a test of significance to "detect" a practical difference (e.g., between the averages of two products that are being compared). A low power typically means that the sample sizes in the study are too small. Without an analysis of statistical power, a conclusion of "non-significant" is rightfully questionable. Unless power is high, a study may be doomed to failure even before it is begun.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Process Capability Analysis of Extremely Non-Normal Data
    Reliability Plotting is a graphical technique that is a standard method described in some reliability textbooks. The method is used primarily for data that is problematic in one or more of the following ways: non-normal (e.g., a Fatigue-Life distribution), a mixture of distributions (e.g., the distribution looks bi-modal when arranged into a histogram), low precision (e.g., a large number of identical readings in a small sample size), and/or incomplete (e.g., when a study is terminated before all on-test devices can be measured, due either to measurement equipment limitations or due to time limitations). Reliability plotting can easily handle all such situations.

  • John N. Zorich Recorded
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    Duration:90 Minutes
    Price: ¤136.00
    by: John N. Zorich
    Process Capability Analysis by means of Confidence - Reliability Calculations
    The webinar begins with a discussion of relevant regulatory requirements, as motivation for calculating "confidence/reliability". Then, some vocabulary and basic concepts are discussed.

  • John N. Zorich Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤189.00
    by: John N. Zorich
    Metrology: Statistical Analysis of Measurement Uncertainty
    The webinar begins with an examination of the fundamental vocabulary and concepts related to metrology. Topics include: accuracy, precision, calibration, and "uncertainty ratios".

  • Rotimi Toki Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Rotimi Toki
    Foreign Bodies in Foods - Effective Techniques for Prevention, Control and Detection
    Foreign bodies are the most obvious evidence of a contaminated product, its presence in foods is among the biggest source of complaint and prosecution in the food industry. To the food processor or manufacturer, foreign body contamination can be costly and may include the cost of a product recall, legal expenses and ultimately, the costs of lost reputation and consumer confidence.

  • Rotimi Toki Recorded
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    Price: ¤189.00
    by: Rotimi Toki
    Food Allergen Programs: Management of Allergen Cross-Contamination and Validation of Cleaning Procedures to Ensure Effective Removal
    Attend this webinar to understand the purpose of cleaning validation. The training session will focus on how to develop a cleaning validation plan related to food allergens, including the sequence of events likely to proceed in a cleaning validation plan, which can be tailored for specific situations. Participants will understand what to consider when choosing sampling and testing methods.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Proven Cleaning and Sanitation Techniques for Food Processors
    Cleaning and sanitation programme are essential to control the hazards of microbiological and physical contamination of foods in the foodservice and food manufacturing facilities. To ensure that a facility and equipment are clean, sanitised and suitable for their intended use, management of the food business must draw up and operate a written sanitation programme and suitable cleaning procedure for all equipment surfaces and structures within the facility.

  • Rotimi Toki Recorded
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    Price: ¤149.00
    by: Rotimi Toki
    Gluten - Free Product: How to Prove & Display It Correctly
    The gluten-free market is one of the fastest growing markets worldwide. For the 18 million Americans who suffer from gluten intolerance, gluten sensitivity or celiac disease, gluten - free products are a necessity. To help assure customer confidence, the FDA issued a final rule in August 5, 2014 that defines gluten - free claims across the food industry. To enforce the final rule FDA may use its full range of routine post- market monitoring activities, including periodic inspections of manufacturer's facilities, food label reviews and gluten analyses of food samples.

  • David Ringstrom Recorded
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    Price: ¤149.00
    by: David Ringstrom
    Reclaiming Large Excel Spreadsheets
    You've likely experienced the "blur" that sets in when you're working in a large spreadsheet. Or the frustration in tasks that consume far more time in Excel than you feel they should.

  • David Ringstrom Recorded
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    Price: ¤149.00
    by: David Ringstrom
    Spreadsheet-Based Internal Controls
    You'll not only learn how to control a user's actions, but you'll also learn how to make your spreadsheets as future-proof as possible. You'll also learn techniques that can significantly save you time when making a spreadsheet as "user-proof" as possible.

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    Building a Validation Program From Top to Bottom
    Companies face many common issues or confusions that arise while creating a validation program such as, Though company has expertise in process validation but never quite able to keep up with facility and equipment changes requiring never ending equipment qualification (IQ, OQ, PQ). Sometimes matrix approach to cleaning validation has gaps or even worse customer or 483 audit findings due to the program's near impossibility to manage. How PLC-based systems or laboratory equipment should fall within the methods validation program, software validation program, or even the equipment qualification program?

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    Building a Sustainable Vendor Qualification Program
    Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

  • Jonathan M. Lewis Recorded
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    Price: ¤189.00
    by: Jonathan M. Lewis
    FDA Inspections - Do's and Don'ts
    Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

  • Mike Morley Recorded
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    Price: ¤149.00
    by: Mike Morley
    IFRS 6 Oil, Gas, Mining and other Extractive Industries
    As a finance or accounting professional, you should be familiar with exactly what these IFRS standards for Extractive Industries consist of, and what they mean for companies in the oil, gas and mining industries. This webinar will help you become acquainted with the latest information regarding IFRS for companies in the resource sector.

  • Mike Morley Recorded
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    Price: ¤149.00
    by: Mike Morley
    Does Anyone Care About SOX Anymore?
    Attend this presentation and find out what the SEC is watching closely for now and into the future. Like it or not, the SEC is still fining companies and filing criminal charges against company executives. Don’t be one of them.

  • Jason Teliszczak Recorded
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    Price: ¤149.00
    by: Jason Teliszczak
    Food Safety - Food defense
    Since the Food Safety Modernization Act of 2010 was signed into law by President Obama on January 4, 2011, Food Defense is now clearly called out and must be adhered to. These requirements mandate FDA’s action in the area of Food Defense, and penalties continue to go higher and higher. With the associated costs related to oversights and recalls, Food Defense is an important economic aspect of any organization.

  • Jason Teliszczak Recorded
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    Price: ¤149.00
    by: Jason Teliszczak
    Food Safety - Food Certifications - What Certification is Best for Your Company?
    Since the Food Safety Modernization Act of 2010 became live in 2011 and the Global Food Safety Initiative (GFSI) began gaining significant ground since 2012, certification is now key to gain and maintain clients as well as ensure compliance. These requirements and mandates push every organization to ensure that they are up to date on their food safety programs. With the associated costs related to oversights and recalls, certification to food safety is an important economic aspect of any organization.

  • Jason Teliszczak Recorded
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    Price: ¤127.00
    by: Jason Teliszczak
    Construction - OSHA Construction Basics, for any Jobsite
    Real world examples of what to expect, and what to prepare for whenever possible. Not every organization is ready to avoid inspections or fines if they do not have senior staff in place, and/or if they have not been audited in the past.

  • Mike Morley Recorded
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    Price: ¤124.00
    by: Mike Morley
    SOX: Internal Controls for Accounts Payable
    This session will raise awareness of fraud issues in Accounts Payable and examine processes to mitigate the risk associated with Accounts Payable to comply with SOX. It will provide you with the tools you need to establish and maintain strong internal controls that meet Sarbanes-Oxley standards by reducing risk and protecting company assets.

  • Dev Raheja Recorded
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    Price: ¤189.00
    by: Dev Raheja
    Software FMEA for Medical Devices
    The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device.

  • Dev Raheja Recorded
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    Price: ¤128.00
    by: Dev Raheja
    Designing Medical Devices for Long Life at Lower Costs
    The number of medical device recalls was up 28% in 2013 and estimated to be even higher in 2014. Learning to design for durability using risk analysis tools the right way at right time can eliminate many life cycle costs such as production rejects, rework, warranty costs, safety litigation costs, and maintenance and repair costs to customers. Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    Cyber Security Mitigation and Response Risk Assessment
    An organization's security policy and controls must be adaptable to emerging threats in today's world. The assessment of security threats is ongoing, and must be mapped against the adequacy and existence of security controls. Security controls and countermeasures that are currently in in place may not commensurate with potential risks. The effort is never ending, but knowing how to start is the key.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    BC ISO 22301: Business Continuity Planning
    ISO panning helps you mitigate in a disaster against loss of business, loss of monies, penalties, legal liabilities, loss of reputation, loss of customers and more.

  • Buddy Baker Recorded
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    Price: ¤149.00
    by: Buddy Baker
    The Impact of Basel III on Export Finance
    New regulations are going to dramatically increase banking charges and exporters are going to be impacted more than most.

  • Brian Perlberg Recorded
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    Duration:90 Minutes
    Price: ¤149.00
    by: Brian Perlberg
    Contract Killer Clauses in Construction: And How to Neutralize Them
    The most important and egregiously written construction contract clauses have been shown to cost a 20% premium on prices and lead to fail projects and litigation. What are examples of poorly drafted killer clauses and how can you avoid them to get better project results.

  • Jason Teliszczak Recorded
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    Price: ¤189.00
    by: Jason Teliszczak
    Medical Devices - ISO 13485
    A detailed look at each section of the standard. Real world examples of what to expect, and what to prepare and repeal within the audit guidelines. What must a documentation system look and feel like to ensure compliance?

  • Casper Uldriks Recorded
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    Duration:90 Minutes
    Price: ¤189.00
    by: Casper Uldriks
    Your Social Media Marketing is Under FDA's Microscope
    Social media has become a primary vehicle for reaching buyers, both professional healthcare providers and consumers. The consumers can post whatever they wish, whether it is true, false, an opinion or simply as a joke.

  • Michael Brodsky Recorded
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    Price: ¤149.00
    by: Michael Brodsky
    Emerging Issues in Food Safety
    This webinar will address the complexity of defining safe food. We will look at the changing nature of foodborne/food transmitted pathogens, new and emerging analytical technologies and the influence of demographics and geography on the changing landscape.

  • Casper Uldriks Recorded
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    Price: ¤189.00
    by: Casper Uldriks
    Manage Your FDA Inspection Before It Happens
    The FDA conducts various types of inspections depending on what the firm is doing. Inspections follow fairly predictable patterns. You can identify what factors are relevant for your inspections and how the FDA will work with them. The goal of the seminar is to help you figure out what is relevant for how FDA looks at you. Establishing a well-reasoned inspectional strategy on the basis of relevant FDA factors, and how an inspection unfolds, you avoid or mitigate unnecessary policies and procedures that are premised on a defensive stance or an ad hoc management style, which is usually so anxiety laden that the firm becomes its own worst enemy.

  • Jason Teliszczak Recorded
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    Price: ¤149.00
    by: Jason Teliszczak
    Aerospace - AS9100 vs ISO 9001
    AS9100 was released in 1999, and was based on ISO 9001. As many different organizations wanted a standard for their industry, ISO 9001 did not cover all of the aspects needed to ensure safe materials and manufactured goods were acceptable for their aerospace applications.

  • Karen Friedman Recorded
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    Price: ¤149.00
    by: Karen Friedman
    Exporting your Dietary Supplements to Canada
    Detailed overview of product license applications required for sale of dietary supplement products in Canada. For dietary supplements the requirements list set out by the Natural Health Product Directorate of Health Canada must be followed to a 't'. Any incomplete applications will be refused.

  • Karen Friedman Recorded
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    Price: ¤149.00
    by: Karen Friedman
    Facing the challenges of Canadian Consumer Health Product Registration
    An introductory overview will begin the webinar providing tools for clarifying the different types of consumer health products available and regulated in Canada, including drugs, cosmetics, natural health products and health foods. This introduction will include a brief discussion on the acceptable package claims for each type of product, and permissible label statements.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    Designing Full Cyber Security Incident Response Team (CSIRT) Training Program as well as Table Top and Simulation Testing
    Attacker's attack 24x7 and Computer Security Incident Response for a company, government agency or organization must also be ready 24X7. Both reporting incidents and disseminating incident-related information correctly is a must.

  • Ms. Michael Redmond Recorded
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    Price: ¤138.00
    by: Ms. Michael Redmond
    Business Continuity and Disaster Recovery Management
    Session covers the Business Continuity Management (BCM) and Disaster Recovery (DR)Process or Function, including resilience strategies, recovery objectives, business continuity and crisis management plans and including obtaining management support and organizing and managing the formulation of the function or process either in collaboration with, or as a key component of, an integrated risk management initiative.

  • Ms. Michael Redmond Recorded
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    Price: ¤149.00
    by: Ms. Michael Redmond
    Resiliency Individual, Community, Business
    Business Continuity Management (BCM) is a holistic management process that identifies potential impacts that threaten an Organization and provides a framework for building resilience with the capability for an effective response that safeguards the interests of its key stakeholders, reputation, brand and value creating activities. This encompasses the management of recovery or continuity in the event of a disaster as well as the management of the overall program through training, rehearsals, and reviews, to ensure the plan stays current and up to date.

  • Heath Rushing Recorded
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    Price: ¤189.00
    by: Heath Rushing
    Statistical Methods for Process Validation
    This course will focus on teaching how to efficiently and effectively apply recommended statistical methods and tools to process validation. Using hands-on exercises (complete with realistic process data), participants will learn how to apply these tools, interpret results, and draw meaningful conclusions throughout Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

  • Heath Rushing Recorded
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    Price: ¤189.00
    by: Heath Rushing
    Quality by Design: Establishing a Systematic Approach to Pharmaceutical Development
    This webinar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles. In addition, this webinar teaches the application of statistics for setting specifications, assessing measurement systems, developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

  • Neal Machtiger Recorded
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    Price: ¤189.00
    by: Neal Machtiger
    Introduction to Industrial Microbiology
    Why are we concerned about microbiology and what has it to do with the manufacture and sale of consumer products What are bacteria, yeasts and fungi? How can the presence of microorganisms pose a threat to the manufacture of qualify products? More simply stated, what are the characteristics of these organisms, where are they found? Now can such organisms affect our products?

  • Thomas E. Colonna Recorded
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    Price: ¤189.00
    by: Thomas E. Colonna
    FDA Regulation of Medical Device Software
    The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).

  • Thomas E. Colonna Recorded
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    Price: ¤189.00
    by: Thomas E. Colonna
    Fundamentals on FDA Regulations of Bioresearch Monitoring
    FDA's bioresearch monitoring program is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research. The BIMO Program was established in 1977 by a task force that included representatives from the drug, biologic, device, animal drug, and food areas.

  • Anne Tomalin Recorded
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    Price: ¤127.00
    by: Anne Tomalin
    Clinical Trials in US, Europe and Canada
    This course will provide an overview of the regulatory requirements to conduct clinical trials in Europe, the US and Canada. Data that is required to be filed and the process for approval of the trial will be reviewed.

  • Anne Tomalin Recorded
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    Price: ¤126.00
    by: Anne Tomalin
    Conducting Observational Studies in US, Canada and Europe
    This presentation will clarify the confusion and illuminate the various requirements across the United States, Europe and Canada.

  • Anne Tomalin Recorded
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    Price: ¤127.00
    by: Anne Tomalin
    Clinical Trial Applications in Canada, and Comparison to the US and Europe
    This topic will cover the regulatory submission required in Canada (Clinical Trial Application) and comparison to Clinical Trial Applications in Europe and Investigational New Drug Submissions in the EU. Also covered will be the submission of documentation to Institutional Review Boards, the membership of these boards, and common findings of deficiencies for such Boards. Again, a comparison will be made to the US and EU.

  • Anne Tomalin Recorded
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    Price: ¤189.00
    by: Anne Tomalin
    International Regulatory Cooperation Among Agencies
    It will also review how agreements are being developed to allow the disclosure of confidential information and discussion of decisions being made. Examples of shared experiences with orphan drugs, cough and cold medications, generic drugs and GMP inspections.

  • Anne Tomalin Recorded
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    Price: ¤189.00
    by: Anne Tomalin
    Current Status of Biosimilars in US, Europe and Canada
    Biosimilars in the US, including new regulations, existing guidelines, direction from Congress, meetings with the FDA, INDs that have been filed and NDAs that have been filed. We will also discuss the current state of affairs in Canada, who seems to be closely aligning itself with Europe.

  • Elisa Harvey Recorded
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    Price: ¤189.00
    by: Elisa Harvey
    Biocompatibility Testing of Medical Devices in the US and Use of ISO-10993
    Biocompatibility testing is an essential and critical component of any US marketing application for a medical device that has direct or indirect contact with humans. This webinar will cover the FDA's existing and recently updated draft guidance on the use of ISO-10993 to determine what testing is necessary, and describe in detail general and specific testing considerations, based on the nature and duration of contact of the medical device with humans.

  • Elisa Harvey Recorded
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    Price: ¤131.00
    by: Elisa Harvey
    Using the Pre-Submission Process to Your Best Advantage
    This webinar will provide a detailed discussion of understanding the scope of the pre-submission process, what information to provide in a pre-submission, how to prepare for a pre-submission interaction with FDA and how to follow up with FDA following a pre-submission interaction. To do this it will primarily reference the guidance document on pre-submissions recently finalized and issued by FDA earlier this year.

  • Elisa Harvey Recorded
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    Price: ¤132.00
    by: Elisa Harvey
    Orphan Devices: Humanitarian Device Exemptions and Humanitarian Use Designations
    An Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations. The HUD provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations.

  • Bernard Markstein Recorded
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    Price: ¤127.00
    by: Bernard Markstein
    Outlook for Multifamily Housing
    This webinar will cover the major issues facing the multifamily housing market with an emphasis on the outlook for new construction. Coverage will include discussion regarding the preference for owning vs. renting, availability of credit for residential purchases by the consumer and for developers, the direction and speed of change in interest rates, the outlook for multifamily condominium units, and availability of labor for construction.

  • Bernard Markstein Recorded
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    Price: ¤139.00
    by: Bernard Markstein
    Outlook for Single-Family Housing
    This webinar will cover the major issues facing housing with an emphasis on single-family new residential construction. Coverage will include discussion regarding the preference for owning vs. renting, availability of credit for residential purchases by the consumer and for developers, and availability of labor for residential construction.

  • Stephen Alvania Recorded
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    Price: ¤141.00
    by: Stephen Alvania
    Airport Traffic Control Tower (ATCT)
    The initial subject focuses on the primary control positions located in the tower. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage aircraft operating on the Airport Movement Area (Ground Control) and within the Airport Traffic Area (Local Control). Also addressed are the operational considerations associated with the close interaction with the Terminal Radar Approach Control (TRACON).

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤143.00
    by: Stephen Alvania
    Terminal Radar Approach Control (TRACON)
    Many people believe that communications, navigation, surveillance, and automation technologies are the elements of the complete ATC system when, in fact, they are simply the enabling technologies that allow the air traffic control function to perform efficiently and safely.

  • Stephen Alvania Recorded
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    Duration:90 Minutes
    Price: ¤135.00
    by: Stephen Alvania
    Air Route Traffic Control Center (ARTCC) Operations
    The initial subject focuses on the primary control positions located in the ARTCC. Each position is discussed to identify the responsibility of the control position and the types of control strategies that are employed to safely and efficiently manage and separate aircraft operating in ARTCC airspace.

  • Norman G. Marriott Recorded
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    Duration:90 Minutes
    Price: ¤124.00
    by: Norman G. Marriott
    Pest Control in Food Processing and Foodservice
    Effective sanitation in the food industry involves the maintenance of clean conditions in the entire food operation including the control of pests such as cockroaches, houseflies, rats, mice, and birds. This status is attained through the prevention of pest entry and eradication of those that infiltrate food establishments.

  • Karen Friedman Recorded
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    Price: ¤143.00
    by: Karen Friedman
    Canadian Establishment Licenses: Drugs and Dietary Supplement Facilities
    Overview of the different licenses for sites involved with exporting, importing and manufacturing of drugs, natural health products and medical marijuana to be provided. Specific focus will be on which information is required for the various types of facility licenses, for both Canadian and non-Canadian buildings involved in the pharmaceutical product supply chain. Sourcing of active pharmaceutical ingredient sources (API) must now be covered in some types of licensing, details will be provided on API requirements with examples using Health Canada’s required application forms.

  • Ronald Kudla Recorded
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    Price: ¤131.00
    by: Ronald Kudla
    The Bayh-Dole Act and Its Implementing Regulations & Rule-Making
    This webinar provides a brief history of the Bayh-Dole Act, where it is managed within the federal government, the invention reporting requirements of grantees to the federal government, an example of how a university coordinates invention reporting requirements to complete timely reporting requirements of the Act. In addition to those provisions that apply to all organizations, non-profit organizations are subject to three obligations that those that seek intellectual property rights via license contracts need to be aware of.

  • Dr. Michael Forstner Recorded
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    Price: ¤146.00
    by: Dr. Michael Forstner
    Drug Safety Risk Management Planning
    Risk Management Plans (RMPs) have become a key topic in Pharmacovigilance (PV) since the 2012 European PV legislation has come into effect. Following the example of the European Union, many other countries have followed the example of the EMA and started requiring detailed plans on how the important risks of therapeutic drugs are to be minimized and/or further characterized.

  • Michael Allocco Recorded
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    Price: ¤133.00
    by: Michael Allocco
    Concepts of Hazard Analysis and Risk Assessment
    Hazard analysis and risk assessment are powerful tools on hand for safety professionals. With additional knowledge of concepts and axioms an analysts should be able to apply these tools effectively.

  • David Ringstrom Recorded
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    Duration:90 Minutes
    Price: ¤145.00
    by: David Ringstrom
    Expedite Excel with Hidden Shortcuts
    Excel expert David Ringstrom, CPA is fond of stating "Either you work Excel, or it works you!" In this fast-paced presentation David will share over two dozen ways that you can reclaim part of your day from Excel. You'll uncover mouse techniques, keyboard shortcuts, hidden menus, and even ways to create your own custom keyboard shortcuts in Excel.

  • David Ringstrom Recorded
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    Price: ¤144.00
    by: David Ringstrom
    Leveraging Linked Workbooks in Excel
    Many Excel users have a love-hate relationship with workbook links. For the uninitiated, workbook links allow you to connect one Microsoft Excel spreadsheet to other spreadsheets, Word documents, databases, and even web pages.

  • David Ringstrom Recorded
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    Price: ¤147.00
    by: David Ringstrom
    Transcend VLOOKUP in Microsoft Excel
    Look-up formulas such as VLOOKUP allow you to return data from other locations in your spreadsheets without linking to individual worksheet cells. However, VLOOKUP can't always return the data that you need. In this session Excel expert David Ringstrom, CPA explores the nuances and limitations of VLOOKUP, helps you expand your use of this function, and then leaves you with a handful of alternatives.

  • David R Dills Recorded
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    Price: ¤155.00
    by: David R Dills
    Complaint Handling and Management: From Receipt to Trending
    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

  • David R Dills Recorded
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    Price: ¤148.00
    by: David R Dills
    Importing and Exporting Medical Devices: A Primer on Regulatory Strategy and Requirements
    Any medical device that is legally in the U.S. may be exported anywhere in the world without prior FDA notification or approval. The export provisions under section 802 of the FD&C Act only applies to unapproved devices. Devices that have not been approved or cleared in the U.S. must follow the export provisions of the FD&C Act. Foreign firms that manufacture medical devices and/or products that emit radiation that are imported into the United States must comply with applicable U.S. regulations before, during, and after importing into the U.S. or its territories.

  • David R Dills Recorded
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    Price: ¤158.00
    by: David R Dills
    Bullet Proof 510(k) – Latest FDA Changes to the Process
    There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.

  • David R Dills Recorded
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    Price: ¤154.00
    by: David R Dills
    Draft Guidance for Device Industry and FDA - Postmarket Surveillance
    This webinar will provide an overview and guidance to firms that are either going through or preparing to go postmarket surveillance activities.

  • David R Dills Recorded
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    Price: ¤190.00
    by: David R Dills
    Combination Products: FDA's Final Rule for GMP Requirements and Introduction and Expectations for "Combo" Products
    What is a combination product? What are some examples of combination products? How are combination products assigned for review? Where can I find guidance for how master files can be used in the submission of information relevant to my combination product? Determine which Center will review my combination or non-combination product?

  • Dr. Ludwig Huber Recorded
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    Price: ¤178.00
    by: Dr. Ludwig Huber
    Auditing Computer Systems for FDA and International Compliance
    Auditing of computer systems is important to verify compliance of the systems with regulations and internal standards. When done right, audits can help to improve quality of computer system operation and uptime.

  • Dr. Ludwig Huber Recorded
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    Duration:75 Minutes
    Price: ¤183.00
    by: Dr. Ludwig Huber
    Calibration and Qualification in Analytical Laboratories
    Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.

  • David R Dills Recorded
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    Duration:75 Minutes
    Price: ¤190.00
    by: David R Dills
    Postmarketing Vigilance Reporting For Medical Device Manufacturers
    Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 6) came into force on January 1, 2008.

  • David R Dills Recorded
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    Price: ¤190.00
    by: David R Dills
    Conducting Successful Product Complaint Investigations
    An effective complaint handling system is an extremely important part of any quality system. Manufacturers should understand that any complaint received on a product shall be evaluated and, if necessary, thoroughly investigated and analyzed, and corrective action shall be taken.

  • Michael Allocco Recorded
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    Price: ¤132.00
    by: Michael Allocco
    Conducting Safety Reviews for Systems, Products, Processes, facilities, and Procedures
    This webinar discusses the concept of conducting an inclusive safety reviews in order to evaluate associated risks and mitigations. Safety axioms appropriate to the safety review concept are discussed.

  • Betty Lane Recorded
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    Duration:90 Minutes
    Price: ¤148.00
    by: Betty Lane
    Corrective Actions - Current Expectation of ISO 13485 and FDA Auditors
    This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity.

  • Betty Lane Recorded
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    Price: ¤147.00
    by: Betty Lane
    Effective Root Cause Analysis: The key to an Effective Corrective Actions System
    In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective.

  • Alla Teresh Recorded
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    Price: ¤144.00
    by: Alla Teresh
    Good Documentation Practices for GxP Compliance
    Documentation is essential for good science. This is especially true in life sciences where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are the set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.

  • Larry Spears Recorded
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    Price: ¤146.00
    by: Larry Spears
    FDA Export Certificates for Medical Devices
    Companies need to stay internationally competitive and this webinar on export certificates provides a key link for entry to markets around the globe. This webinar will explore the export approval and certification process in the U.S. It will include guidance on preparing applications and obtaining FDA's certification that specific products identified for export meet U.S. regulatory requirements. All of this will be valuable in obtaining broader access to global markets.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤142.00
    by: Miles Hutchinson
    Nonresident Alien W-8 & 1042-S Compliance Update
    We will begin with the methods of identifying workers who may be non-resident aliens and proceed to the forms and methods of collecting the necessary information to determine whether back-up withholding is required. Next we will examine the rules and forms for proper depositing of back-up withholding taxes and the required reporting to the worker as well as to the IRS. Please note, beginning in 2014 the number and complexity of the forms have both increased due to the implementation of FATCA, the Foreign Accounts Tax Compliance Act.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤146.00
    by: Miles Hutchinson
    How to Design and Implement Outstanding KPI Performance Dashboards
    Grab a cup of coffee and join us to learn how to improve your KPI focus, and juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales. Ensure your Performance Dashboards are crisp, attention grabbing and clearly identify significant performance trends. Know whether your business is meeting or exceeding its goals with your early warning system of leading and trailing performance indicators.

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤145.00
    by: Miles Hutchinson
    Introduction to Sales and Use Taxation
    This webinar will discuss legal developments in the area of taxation of internet sales

  • Miles Hutchinson Recorded
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    Duration:90 Minutes
    Price: ¤190.00
    by: Miles Hutchinson
    Financial Statement Preparation and Analysis
    Grab a cup of coffee and join us to learn how to analyze the numbers, and use this intel to juice up virtually every facet of your organization's operations from marketing, to finance, to HR, to customer service and sales.

  • Thomas E. Colonna Recorded
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    Duration:90 Minutes
    Price: ¤134.00
    by: Thomas E. Colonna
    FDA Regulation of In Vitro Diagnostics
    In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers. IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.

  • Thomas E. Colonna Recorded
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    Price: ¤138.00
    by: Thomas E. Colonna
    FDA Regulation of Combination Products
    A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.

  • Thomas E. Colonna Recorded
    View Anytime
    Price: ¤137.00
    by: Thomas E. Colonna
    FDA Regulation of Dietary Supplements
    FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products.

  • Omid Khodai Recorded
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    Price: ¤146.00
    by: Omid Khodai
    Good Clinical Practice (GCP)
    Good clinical practice (GCP) is an international quality standard that is provided by ICH, an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.

  • Omid Khodai Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤148.00
    by: Omid Khodai
    How to Survive an FDA Inspection
    Bioresearch monitoring program or BIMO is a comprehensive, agency-wide program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research

  • Larry Spears Recorded
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    Duration:90 Minutes
    Price: ¤147.00
    by: Larry Spears
    Medical Device Registration & Listing, and Inspection Follow-up Activities
    Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. The stakes are made even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety.

  • Mark Brengelman Recorded
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    Price: ¤131.00
    by: Mark Brengelman
    Regulation of the Practice of Geology in the United States
    Today's educated professionals in the earth sciences function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. With environmental issues and the use of our natural resources a pressing concern, how does one understand and utilize geology? How is geology different from civil engineering?

  • Karl Leinsing Recorded
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    Price: ¤147.00
    by: Karl Leinsing
    Medical Device Product Development Process
    We will give you the steps and information to develop a medical device product. The documentation discussed can also be used and is often requested by the FDA and required by many ISO procedures for controlling the design process. We will discuss why certain steps are so important in the design process and that many steps are not just wasted time and paperwork.

  • Angela Bazigos Recorded
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    Price: ¤157.00
    by: Angela Bazigos
    Excel Spreadsheet Validation for FDA 21 CFR Part 11
    This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

  • Fred Vacelet Recorded
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    Duration:90 Minutes
    Price: ¤140.00
    by: Fred Vacelet
    Stress-Testing for Financial Institutions, Beyond Regulatory Constraints
    Stress-testing requires lateral knowledge and skills to be thoroughly pursued and constantly updated. It is no longer enough to neglect low-likelihood risks, even when there few or no past occurrences of these risks, and if the perspective looks far away.

  • Angela Bazigos Recorded
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    Duration:90 Minutes
    Price: ¤163.00
    by: Angela Bazigos
    Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)
    This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow.

  • Angela Bazigos Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤167.00
    by: Angela Bazigos
    FDA's enforcement of 21 CFR part 11 compliance
    This presentation will cover the scope, status and results of the surveillance inspections and what they may mean for the future of 21 CFR Part 11. This will enable you to determine whether your company is subject to the most common violations so you can take action to have a better inspection outcome.

  • Drex Rutledge Recorded
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    Duration:90 Minutes
    Price: ¤124.00
    by: Drex Rutledge
    Introduction to Program-Project Management
    This webinar will focus on identifying the critical components that a Project or Program Manager must be aware of and how to develop plans for effectively and efficiently dealing with them.

  • James Bone Recorded
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    Price: ¤148.00
    by: James Bone
    Anti-Money Laundering (AML) -Connecting the Dots
    The core components of AML are simple however the execution of effective Know Your Customer compliance is very complex. If you would like to gain stronger assurance about the effectiveness of your AML program using data analytics this webinar is designed to help you develop a simple analytical model for improving the assurance of your AML program.

  • James Bone Recorded
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    Price: ¤152.00
    by: James Bone
    Why Good Risk Management is so Elusive
    Whether you are new to risk management or a seasoned veteran tuning up your risk program is constantly required. This program, "What good risk management is so elusive" is designed to make the process of risk management simple.

  • Larry Spears Recorded
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    Price: ¤148.00
    by: Larry Spears
    Medical Device Recalls
    Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing.

  • Denise Cicchella Recorded
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    Duration:90 Minutes
    Price: ¤137.00
    by: Denise Cicchella
    Auditing Enterprise Risk Management
    In 2004, the Committee of Sponsoring Organizations of the Tread way Commission (COSO), issued a principle-based guidance on designing and implementing an effective enterprise-wide approach to risk management. This guidance defines essential components - such as risk appetite, risk tolerance and portfolio view, provides guidance using common principles, and provides counseling and strategy for an effective program.

  • Denise Cicchella Recorded
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    Price: ¤141.00
    by: Denise Cicchella
    Foreign Corrupt Practices Act - Audits Role
    The United Nations Convention Against Corruption was formed as a committee in 2003 to help combat what was being seen as an epidemic against free trade. Organizations working in the international arena now face greater regulatory challenges to continue practicing, to educate their employees, and to monitor for violations. The legal loophole is spreading and the FCPA has recently held financial institutions liable for not reporting clients who fail to comply with FCPA requirements.

  • John E Lincoln Recorded
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    Price: ¤162.00
    by: John E Lincoln
    Meeting Annual U.S. FDA cGMP Training Requirements
    There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance audits. These changes in focus have a major impact on individual compliance objectives, efforts and measurements of success.

  • John E Lincoln Recorded
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    Duration:90 Minutes
    Price: ¤141.00
    by: John E Lincoln
    Device Changes, FDA Changes, and the 510(k)
    The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

  • John E Lincoln Recorded
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    Duration:60 Minutes
    Price: ¤137.00
    by: John E Lincoln
    Product Risk Management - ISO 14971:2007
    This webinar will address the use of the ISO 14971 model to perform and document such activities and the additional actions necessary to make it a useful product reference and training tool.

  • John E Lincoln Recorded
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    Price: ¤190.00
    by: John E Lincoln
    Setting Up and Running a Tougher Supplier Audit Program
    The last few years have seen the U.S. FDA come under increasing negative public scrutiny. High profile drug recalls, food chain problems and contamination, import problems, resignations. Now a new commissioner vows no more "business as usual". Data in submissions and decisions rendered will be more science based.

  • John E Lincoln Recorded
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    Price: ¤190.00
    by: John E Lincoln
    CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations
    Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.

  • Susan Brink Recorded
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    Price: ¤144.00
    by: Susan Brink
    Electronic Informed Consent for clinical trials: Why, What and How
    An analytical method is a process. The FDA process validation guidance applies to test methods, like all other processes in the pharmaceutical industry. Therefore, the laboratory or laboratories must demonstrate that a test method performs as intended through the method lifecycle.

  • John Ryan Recorded
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    Price: ¤128.00
    by: John Ryan
    Traceability and Recall Through Food Processes
    This 60 minute webinar will cover traceability requirements and techniques useful in the event of quality deviation investigations and potential FDA Recalls. The session will also cover associated information like identification, classification and protocols.

  • John Ryan Recorded
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    Duration:75 Minutes
    Price: ¤126.00
    by: John Ryan
    Food Import Detections and Seizures: The Current and Future Regulatory Environment
    With $49 billion worth of imported foods, the FDA and its regulatory allies oversee more than 420,000 domestic and foreign facilities.

  • Lynne Hare Recorded
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    Duration:75 Minutes
    Price: ¤126.00
    by: Lynne Hare
    The Strategy of Experimentation
    Research resources are too scarce to be squandered going down blind alleys and coming up empty handed at project end. We can no longer afford to play hunches or to rely on so called experts, whose opinions all differ, to guide research. Nor can we rely on the gross inefficiencies of old-fashioned one-factor-at-a-time experimentation to guide decisions. Instead, R&D must proceed systematically and with a goal of using unbiased data to guide decisions, following an overall strategy guided by statistical thinking and the scientific method.

  • Dev Raheja Recorded
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    Duration:90 Minutes
    Price: ¤146.00
    by: Dev Raheja
    Software FMEA for Medical Devices
    The Failure Mode Effects Analysis breaks down the analysis of complex software functions into manageable subsystems and modules. It can have a number of variations which address different aspects of the device.

  • Donald Jones Recorded
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    Price: ¤127.00
    by: Donald Jones
    Environmental Cleaning
    Companies must provide effective Food Safety training for all employees including managers, supervisors, sanitation employees and production employees in order to produce a safe quality food product. Proper Environmental Cleaning is just as important as the cleaning of the "inside" of food processing equipment. The exterior of equipment, floors, walls, ceilings, doorways and drains can be a major source of microbial contamination if not properly controlled.

  • Shari Storm Recorded
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    Price: ¤132.00
    by: Shari Storm
    Capturing the Most Powerful Market - Moms
    Moms control 85% of all household spending. Moms hold the biggest influence on what brands their children will buy. Moms have strong online networks and rely on referrals from other moms. Make a mom happy and you’ve got the whole family plus all of her friends as new members.

  • Richard Melancon Recorded
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    Price: ¤138.00
    by: Richard Melancon
    Owner's Guide to Understanding Financial Statements
    In one hour, you can master the art of reading and understanding your financial statements. No formal accounting training is necessary. No homework will be assigned. And, the information is valuable immediately and forever for your current business.

  • Jonathan M. Lewis Recorded
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    Price: ¤158.00
    by: Jonathan M. Lewis
    Building a Sustainable Vendor Qualification Program
    Documented vendor qualification prior to using a vendor of products or services is a regulatory requirement for FDA regulated industries. The decisions where to purchase components, raw materials, manufacturing and testing equipment, and even consulting services, need to be predefine and documented through a vendor qualification program. The results of making poor purchasing decisions can lead to situations that impact product quality, regulatory compliance, company profits, and even the reputation of the company.

  • Jonathan M. Lewis Recorded
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    Price: ¤161.00
    by: Jonathan M. Lewis
    FDA Inspections – Do's and Don'ts
    Most federal laws concerning the FDA are part of the Food, Drug and Cosmetic Act which are codified in Title 21 of the United States Code. However, the language in the law and regulations is often very vague and difficult to interpret. Hence, FDA inspections often result in observations and compliance actions that cost manufacturers and marketers of FDA regulated products hundreds of hours and sometimes millions of dollars to address to the satisfaction of the agency.

  • Carol Friedhoff Recorded
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    Price: ¤132.00
    by: Carol Friedhoff
    Key Steps to Successful Project Management Principles
    A project is a temporary endeavor undertaken to create a unique product, service or result. Project management is the application of knowledge, skills, tools and techniques to project activities to meet the project requirements. Companies have come to recognize the importance of project management in helping them achieve their objectives and have added this to their organizational structure. Project management started with the construction industry and has evolved over time.

  • Brian Perlberg Recorded
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    Price: ¤146.00
    by: Brian Perlberg
    What Contractors Need to Know About AIA A201 and Consensus Docs Contracts
    Why are the top things you need to need to consider changing to standard construction contracts, as well as filling out the blanks correctly! Consequential Damages? Payment Terms? Project Financial Information, Termination? Dispute Mitigation Procedures? The answer is you need to be aware of all the top terms to stay on top of your game.

  • David Ringstrom Recorded
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    Price: ¤152.00
    by: David Ringstrom
    Reclaiming Large Excel Spreadsheets
    You've likely experienced the "blur" that sets in when you're working in a large spreadsheet. Or the frustration in tasks that consume far more time in Excel than you feel they should.

  • David Ringstrom Recorded
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    Price: ¤153.00
    by: David Ringstrom
    Spreadsheet-Based Internal Controls
    You'll not only learn how to control a user's actions, but you'll also learn how to make your spreadsheets as future-proof as possible. You'll also learn techniques that can significantly save you time when making a spreadsheet as "user-proof" as possible.

  • Karen Greene Recorded
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    Price: ¤148.00
    by: Karen Greene
    Sample Size and Statistical Rationale for Medical Device Packaging Validations
    Compliance to ISO 11607, Parts 1 and 2 require that Packaging Validations include the development of a statistical rationale to support the testing conclusions of sterile barrier systems and packaging processes. Learn the basics of a process for developing a validation statistical rationale for packaging sterile barrier systems and processes.

  • Louis Angelucci Recorded
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    Price: ¤153.00
    by: Louis Angelucci
    Similarities and Differences Between an FDA and MHRA Audit
    Having participated in both FDA and MHRA audits for the same facility and practices it is interesting that different results and major observations are encountered. In order to meet the expectations of both regulatory bodies we need to review and understand the requirements and approach of both bodies. This webinar will review these and compare some of the similarities and differences.