Webinar Search Results : 101 Upcoming webinars found.
Steven Walfish Thursday, January 10, 2017
11:00 AM PST | 02:00 PM EST
Duration:60 Minutes
Price: ¤340.00
by: Steven Walfish

Dr. Afsaneh Motamed Khorasani Friday, September 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
How to Prepare a Standard Operating Procedure (SOP)
Standard Operating Procedures (SOPs) are required for companies that are regulated. However, there is no guidance available by regulatory bodies on how to write, maintain, and update SOPs. Often, SOPs are prepared in a way that makes compliance difficult, leading to errors or delays that will be discovered during an audit.

Eleonora Babayants Friday, September 21, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Data Integrity in Compliance with GXP-GMP Regulations
There are GMP requirements for information technology. For a drug to be produced in a GxP/GMP compliant manner, some specific information technology practices must be followed. Computer systems involved in the development, manufacture, and sale of regulated product must meet certain requirements.

Yingying Liu Friday, September 21, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Yingying Liu
Clinical Trial Applications in China
China FDA (CFDA), now renamed as CNDA, made a series of significant changes to the clinical trial regulations, issuing a large number of guidelines and opinions in Chinese.

Carolyn Troiano Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar Computer System Validation (CSV) for FDA-Regulated Computers
FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. This webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards.

David Nettleton Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: David Nettleton
3-Hour Virtual Seminar on Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Amer Alghabban Monday, September 24, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar the Do's and Don'ts Before, During, and After an FDA GCP Inspection
Good Clinical Practice (GCP) inspection by the US Food and Drug Administration (FDA) can lead to the detection of problems with the conduct of your clinical trial. FDA requirements regarding GCP and related inspections have been around for decades.

John E Lincoln Tuesday, September 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on DHF, DMR, DHR, TF , Design Dossiers - The Requirements
This webinar will examine the existing and proposed requirements for the U.S. FDA's DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3 including its derivative documents, the DMR and DHR. It will consider the European Union's MDD TF/DD and its transition to the EU MDR requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed.

Ginette Collazo Tuesday, September 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Charles H. Paul Tuesday, September 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Implementing Effective CAPA Systems
How CAPA's are executed and managed is crucial to maintaining a compliant organization. Inadequate CAPA processes continue to be a major GMP deficiency and consistently make the FDA's top five list for adverse observations.

Lynn Fountain Wednesday, September 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Critical Concepts to Understand the Balance Sheet, Income Statement, Cash Flow and Retained Earnings
Rather than focus on the computations and tactics of each of the statements, this training program will cover the important concepts of how the statements interact and relate to each other providing management with the critical information needed to manage financial stability of their organization.

Angela Bazigos Wednesday, September 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
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.

John Chapman Thursday, September 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Corrective and Preventive Action
This webinar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements.

Angela Bazigos Thursday, September 27, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
Excel Spreadsheets for 21 CFR 11 Compliance
Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.

Dr. Ludwig Huber Thursday, September 27, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Dr. Ludwig Huber
3-Hour Virtual Seminar on Validation, Verification and Transfer of Analytical Methods - Implementing Guidelines from FDA-EMA, USP and ICH
The 3-hour virtual seminar will give attendees the background to understand the requirements and even more importantly it will focus on strategies and provide tools to implement even most critical requirements.

Tom Fragale Friday, September 28, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Tom Fragale
PowerPoint Tips and Tricks
Even in today's online world, live, face-to-face presentations are still so crucial. That includes presentations of all types: training, sales, staff meetings, stock holder summaries, new company policies, church or organization meetings, fundraisers, etc. Microsoft PowerPoint is still the gold-standard of presentation tools. Because it comes with Microsoft Office and Office 365, most computers have access to the program. But you still have to learn how to use this powerful program the proper way.

Angela Bazigos Monday, October 1, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Data Integrity - FDA's Latest Thinking
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.

David Nettleton Tuesday, October 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: David Nettleton
Excel Spreadsheets - Step-By-Step Instructions for Ensuring Data Integrity
This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet application.

Dennis Taylor Tuesday, October 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Mastering Excel Pivot Tables
PivotTable capabilities are enormous; among its many tools and features.

Edwin Waldbusser Tuesday, October 2, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Medical Device Hazard Analysis Following ISO 14971
The US FDA expects that as part of a product development Design Control Program risk management will be conducted. FDA recommends using ISO 14971 as a guide and has accepted it as a recognized standard. One of the techniques described in ISO 14971 is Hazard Analysis. This is the most powerful of the risk management techniques because it considers risks in normal operation as well as fault conditions. FMEA and FTA consider only fault conditions and are more suited as reliability tools than as product safety tools.

John E Lincoln Wednesday, October 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: John E Lincoln
Verification vs Validation-Product, Process or Equipment and QMS Software
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.

John N. Zorich Wednesday, October 3, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John N. Zorich
Process Validation: Statistical Justification for Sample Size and the Use of Only 3 Lots
This webinar explains how to choose and justify a sample-size for Lots that are included in Process Validation studies.

Susanne Manz Thursday, October 4, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Secrets to Writing Effective SOPs for Medical Device QMS
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed. More importantly, well written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes and quality work.

Roger Cowan Monday, October 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Control of suppliers such as Contract Manufacturing Organizations (CMO) has always been a requirement of the FDA and EU. With the issuance of these new regulatory documents the expectation is that there will be a written documentation of this control. Proof of this control can be presented to FDA / EU inspectors in the form of a Quality Agreement which is specific to a particular CMO. This webinar will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory perspective.

Angela Bazigos Monday, October 8, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
European Data Protection Regulation - 2018 Implementation
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.

Robert J. Russell Tuesday, October 9, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
EU Medical Device Regulation (MDR) - Updated CE Marking Process & ISO 13485:2016 Expectations
This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Charles H. Paul Tuesday, October 9, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
Project Management for Non-Project Managers
This webinar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution to occur and will provide the foundation and direction for future study of the subject.

Dr. Ludwig Huber Wednesday, October 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Validation and Use of Excel® Spreadsheets in FDA Regulated Environments
Excel® Applications are widely used in laboratories, offices and manufacturing e.g., for data capture, data manipulation and report generation.

Lynn Fountain Wednesday, October 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Complying with the Revenue Recognition Standard
This FASB revenue recognition standard webinar will discuss the various steps involved in this standard and also the technical guidance to prepare a revenue recognition model.

Danielle DeLucy Wednesday, October 10, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Danielle DeLucy
Implementation and Management of GMP Data Integrity
Data integrity is the assurance that data records are accurate, complete, intact and maintained within their original context, including their relationship to other data records. This definition applies to data recorded in electronic and paper formats or a hybrid of both.

Dr. Afsaneh Motamed Khorasani Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation Guideline (Chapter 1029 USP)
Good Documentation Practices (GDP) is a critical and essential part of a regulated environment (pharmaceutical and medical device manufacturing, R&D, laboratories and clinical trials). Compliance with GDP ensures an auditable account of work. It ensures integrity and control of documents and is a key requirement for a developed quality system.

Roger Cowan Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
Pharmaceutical Compressed Air - Quality GMP Requirements - What you need to know to Meet FDA and International Quality Standards
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

Carolyn Troiano Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
FDA's New Draft Guidance on Software and Device Changes and the 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.

Laura Brown Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
EU General Data Protection Regulation (GDPR): Compliance for Drug development and Clinical Trials?
The General Data Protection Regulation (GDPR) is new legislation that had come into force on 25th of May 2018 brings substantial changes to the rules around personal data and its use. While it aims at building on existing Data Protection legislation, it represents a significant change for organisations that hold and process personal data particularly for clinical trial data and drug development.

Eleonora Babayants Friday, October 12, 2018
07:00 AM PDT | 10:00 AM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eleonora Babayants
Change Control Procedures in Regulated Industries
GxP/GMP regulations are required to be used in regulated industries such as food and beverages, pharmaceutical, medical devices, and cosmetics. According to these regulations, change control procedures have to be used. Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner.

Wayne Taylor Friday, October 12, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Wayne Taylor
Medical Devices - Complying With 820.250 Statistical Methods
Learn how to manage Statistics including establishing a policy along with procedures relative to specific areas of applications. Highlighted are statistical techniques for:

Tom Fragale Monday, October 15, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Mastering Macros in Microsoft Excel
Don't be afraid of macros - learn how to create and use them. When you find yourself repeating actions in Excel - whether it's a five-step sequence you use when formatting a certain cell type or the 30 steps you use when you sort, filter, and print multiple worksheets once a week, the possibility exists that you can automate these actions in the form of a macro. Thereafter, you can perform these sets of actions with a simple keystroke combination, a button in a worksheet, or by using a button in the Quick Access toolbar.

David Nettleton Monday, October 15, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: David Nettleton
Data Integrity: Compliance with 21 CFR Part 11, SaaS-Cloud, EU GDPR
This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR).

Ginette Collazo Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Ginette Collazo
3-Hour Virtual Seminar on How to Implement an Effective Human Error Investigation Program
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented.Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Robert J. Russell Tuesday, October 16, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Robert J. Russell
3-Hour Virtual Seminar on Japan - Regulatory Filing Requirements and Compliance Processes for Life Sciences
This 3-hour webinar covers the details of the Regulatory Requirements for a wide-range of Life Science products in Japan: Pharmaceuticals, Biologics, Medical Devices and Combination Products. The syllabus also covers the change in Japan caused by the re-write of the Pharmaceutical Affairs Law [PAL] into the Pharmaceuticals & Medical Device Law [PMDL] and the country's latest update to GMP requirements.

Lynn Fountain Wednesday, October 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Risk Based Internal Auditing - Establishing the Methodology
True RBIA incorporates cascading the process through to each individual audit as well as the audit reporting process. The training program will focus on the establishment of a framework or methodology for RBIA and examine how to utilize risk-based questions within the process steps.

Angela Bazigos Wednesday, October 17, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
FDA's 21 CFR 11 Add-On Inspections - Recent Updates
In December 2010 FDA started the Part 11 inspection initiative. While originally the initiative was supposed to last 3-6 months, it has now turned into an ongoing program with Part 11 related issues being part of most future inspections. At the beginning of the initiative FDA made it very clear that Part 11 is in effect and is enforced according to the original Part 11 and the Guidance from 2003. In the meantime FDA officials reported about key findings. For example, George Smith who heads up FDA's Part 11 working group gave an update with examples of violations.

John Chapman Thursday, October 18, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: John Chapman
Medical Device Complaints, MDRs & Recalls
This webinar will help you to understand complaint handling processes and to reap the benefits of valuable product feedback. The identification of the problem, actual cause of the problem,documentation and regulatory reporting is discussed.Consequences of inadequate investigations are pointed out,including FDA Warning Letters and financial losses.The presentation will also review the regulations and point out some of the pitfalls as well as benefits of complaint handling and reporting.

Lamont M. Fulton Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Lamont M. Fulton
Evaluating and Selecting a CMO
Pharmaceutical firms must establish clear process of selecting a Contract Manufacturing Organization to perform the selected task or need. It is incumbent on the Pharmaceutical firm, large or small, to develop a criteria for evaluating a CMO.

Emil W Ciurczak Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak

Eyal Lerner Friday, October 19, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Eyal Lerner
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization
Many medical devices are distributed in USA and in the European Union (EU). Each market has its own regulatory requirements which mainly focused on its quality management systems (QMS). The two QMS are described in two documents, one by the international ISO standard 13485 and the other by FDA Quality System Regulation (21CFR820).

Amer Alghabban Friday, October 19, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar - Good Pharmacovigilance Practice
Pharmacovigilance or drug safety -is a broad term that describes the Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. Before a medicine is authorised for use, evidence of its safety and efficacy is limited to the results from clinical trials, where patients are selected carefully and followed up very closely under controlled conditions.

Dr. Ludwig Huber Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:75 Minutes
Price: ¤150.00
by: Dr. Ludwig Huber
Understanding the USP Chapter 1224 for Transfer of Analytical Methods
When validated methods are transferred between laboratories and sites, their validated state should be maintained to ensure the same reliable results in the receiving laboratory.

Laura Brown Monday, October 22, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Laura Brown
2-Hour Virtual Seminar on Data Integrity for GXP Compliance
Data Integrity is a critical issue in document governance. It increasingly becoming a focus for regulatory inspections globally. This webx session will equip you with knowledge necessary to identify and avoid potential Data Integrity issues before auditors do.

Robert J. Russell Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Robert J. Russell
BREXIT - What's Changing for Life Science Product License Holders-Manufacturers and What you Need to do Right Now
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.

Carolyn Troiano Monday, October 22, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
The 21st Century Cures Act - Expediting New Products and New Product Indications
The 21st Century Cures Act (Cures Act), signed into law on December 13, 2016, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.

Roger Cowan Tuesday, October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Roger Cowan
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product.

John E Lincoln Tuesday, October 23, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: John E Lincoln
3-Hour Virtual Seminar on 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. Starting with a Master Validation Plan, evaluating its elements against ISO 14971 hazard analysis / risk management, allows development of meaningful product validations. The roles of different V&V protocols.

Angela Bazigos Tuesday, October 23, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Analytical Method Validation Process
Use of analytical methods is widespread. However, there are no formally accepted guideline or formats for the overall process of design, development, optimization & validation of analytical methods.Many analytical methods, lacking full and adequate validation have been introduced into the open literature and allowed to assume aura of authenticity but, they may never work or be useful with samples that are typically encountered.

Edwin Waldbusser Tuesday, October 23, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Edwin Waldbusser
Computer System Validation
FDA requires that all software in computer systems used in GxP activities must be validated. Validation of computer system software is completely different than validation of device software (embedded software). Validation is more than testing. It is testing plus design control and configuration management.

Thomas Bento Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Thomas Bento
Validation of Non-Product Software
This course will teach how to comply to 21 CFR Part 820.70(i) and effectively implement a software validation program for medical devices, meeting the FDA requirements and produce a safe product. We will explain the role of Risk Management in Non-Product Validation. How software requirements are used in validation will be described.

Ginette Collazo Wednesday, October 24, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Training in Human Error: Reducing Training Related Errors
We will discuss elements of the training programs like curricula, training management systems, training effectiveness and other important elements of a compliant training program.

Dr. Shuguang Huang Thursday, October 25, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:2 Hours
Price: ¤190.00
by: Dr. Shuguang Huang
2-Hour Virtual Seminar - Biomarker Development and Validation - A Statistical Perspective
Biomarker is very critical in pre-clinical drug discovery, clinical translational research, diagnostic product (including companion diagnostic) development. This webinar will focus on three areas:

Dennis Taylor Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Time-Saving Excel Tips, Tricks and 100 Shortcuts
Microsoft Excel has a tremendous amount of capability and features and is filled with shortcuts and methods not always visible to the casual user. Whether it's a keystroke shortcut or a hidden command sequence, such shortcuts can make you much more proficient and productive as you use this powerful and popular software.

Susanne Manz Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Essentials of Validation - IQ, OQ, PQ
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management

Danielle DeLucy Thursday, October 25, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Angela Bazigos Friday, October 26, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:3 Hours
Price: ¤290.00
by: Angela Bazigos
3-Hour Virtual Seminar on Deciding When to Submit a 510(k) for a Change to an Existing Device
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).

Marina Malikova Friday, October 26, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
Trial Master File Requirements and Essential Regulatory Documents
Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.

Charles H. Paul Monday, October 29, 2018
09:00 AM PDT | 12:00 PM EDT
Duration:60 Minutes
Price: ¤150.00
by: Charles H. Paul
FDA Best Audit Behavior Practices - Do's and Don'ts
This webinar will begin by discussing and emphasizing the importance of truthfulness to the process - truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

Angela Bazigos Wednesday, October 31, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
How to Implement Lean Documents and Lean Document Control to Cut Costs, while Maintaining Compliance with Regulatory Authority Requirements
This webinar will show you how to implement lean documents and lean document control to cut costs, while maintaining compliance with regulatory authority requirements.

Yingying Liu Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Yingying Liu
Pharmaceutical Drug Registration in China
Bringing pharmaceutical products to market in China has become much easier for foreign companies. The Chinese FDA (CFDA), now renamed as CNDA, recently made a series of significant changes to the marketing authorisation regulations by issuing a large number of guidelines and opinions (in Chinese).

Lynn Fountain Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Becoming a Chief Audit Executive - Leading the Internal Audit Function
This training program will enumerate the IIA Standards and the auditor's responsibility to abide by the standards. The program will also look at management's expectations of internal audit and detail skills required for internal audit management. It will provide real-world examples and challenges facing today's internal audit.

Rayleen M. Pirnie Thursday, November 1, 2018
10:00 AM PDT | 01:00 PM EDT
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Handling Consumer ACH Disputes: Advanced ACH Sticky Situations
This ACH training program will review common consumer issues and situations while handling ACH disputes. It will guide participants in deciding the appropriate course of action in given situations. Participants will also learn what to do when a customer/member won't complete a WSUD.

Wayne Taylor Monday, November 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Wayne Taylor
Validation Sampling Plans for Process Validation, Design Verification and CAPA Effectiveness Checks
This course is designed to help you select sampling sizes and acceptance criteria for one-time studies like process validation, design verification, component qualifications and CAPA effectiveness checks including:

Jerry Lanese Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Jerry Lanese
Laboratory Investigation of Out-of-Specification Results
The objective of this webinar is to develop an understanding of how a compliant laboratory handles the investigation of out-of-specification (OOS) test results and how the laboratory interfaces with other units through the laboratory investigation process. The discussion will be based on the FDA guidance on handling OOS laboratory results.

Marina Malikova Tuesday, November 6, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Marina Malikova
ICH GCP Guidelines E6 Revision, R2 Addendum- Changes Impacting Sponsors-CRO-Sites
Managing clinical trials, of any size and complexity, requires strategic planning and efficient execution. As scientific advances continue, the types of therapies being developed have higher potency and novel targets; and increased pressure to have study designs that speed up clinical development.

Derk Yntema Wednesday, November 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Derk Yntema
3-Hour Virtual Seminar on GDPR - European Privacy Regulation what and how
The GDPR (General Data Protection Regulation) compels companies that process Personally Identifiable Information (PII) of European citizens to demonstrate their insight in all PII processing in their business. After assessment by a Data Protection Officer (DPO), they should implement appropriate organizational and technical controls.

Susanne Manz Thursday, November 8, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Root Cause Analysis for CAPA - Myths, Challenges, and Best Practices
This webinar will help you understand the critical ingredients for conducting an effective root cause analysis. You will learn about FDA expectations, tools and techniques, and tips for conducting and documenting root cause analysis. We will discuss the myths, challenges, and best practices for this critical process. We'll also cover the essentials of doing a failure investigation.

Dennis Taylor Thursday, November 8, 2018
09:00 AM PST | 12:00 PM EST
Duration:2 Hours
Price: ¤190.00
by: Dennis Taylor
2-Hour Virtual Seminar on Mastering Excel Pivot Tables
You will learn the following in this webinar, The quickest and best ways to create PivotTables and Pivot Charts, including these capabilities:

Tom Fragale Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Tom Fragale
Advanced Formulas & Functions in Excel
In the business world, or within your organization, you probably experience large amounts of data. Maybe the data is about your sales, customers, donations, orders, employees, vendors, expenses, or whatever it may be.

Dr. Shuguang Huang Friday, November 9, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Dr. Shuguang Huang
3-Hour Virtual Seminar - Assay Validation According to CLSI Guidelines
Bioassay development and validation is very critical in pre-clinical drug discovery, clinical biomarker and translational research, diagnostic product (including companion diagnostic) development. In this presentation, overview if given for the terminologies, the scientific principles, and the regulatory guidelines that are related to assay validation.

Dr. Afsaneh Motamed Khorasani Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Afsaneh Motamed Khorasani
Good Documentation and Record Keeping Best Practices (FDA & EMA)
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified.

Danielle DeLucy Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Danielle DeLucy
How to Conduct Successful Supplier Audits
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.

Carolyn Troiano Friday, November 9, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Carolyn Troiano
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Computer system validation has been regulated by FDA for more than 30 years, as it relates to systems used in the manufacture, testing, distribution and management of a product in the pharmaceutical, biotechnology, medical device, animal health, tobacco and other regulated industries.

Laura Brown Monday, November 12, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Write SOPs which are Compliant for Inspections for a GXP Compliance
This webinar will help Sponsors, CROs in the US, EU and internationally,understand how to write SOPs to comply with inspection requirements.

Angela Bazigos Tuesday, November 13, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Angela Bazigos
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.. After this event, you will be fully prepared for cGMP regulatory inspections in those countries.

Susanne Manz Thursday, November 15, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Risk Management Techniques for Medical Devices
Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971, and how to create processes and procedures to implement them.

Amer Alghabban Friday, November 16, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Amer Alghabban
3-Hour Virtual Seminar Data Integrity in Clinical Trials
Clinical trials' data gives an accurate representation of what we measure to evaluate effects of the treatments under comparison. The clinical data recording process, however, as inspected/audited by inspectors/auditors is initiated with the recorded data, either in the Case Report Form, or in some other system, or in an electronic database.

Emil W Ciurczak Friday, November 16, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Control-Analysis Instrumentation used in PAT and Continuous Manufacturing
We will briefly discuss how to go from minimum sampling, sending them to a lab, and waiting for results, to real-time monitoring, taking huge numbers of readings, and how to understand and apply these data to control and improve new and existing products.

Rayleen M. Pirnie Friday, November 16, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
The Board of Directors Role in Cybersecurity
This webinar will break down the Board's role in effectivecybersecurity oversight, the 12 questions a board member should be knowing to answer, key principles of oversight, tips and resources for board.

Lynn Fountain Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Lynn Fountain
Auditing and Examining Travel and Entertainment Expenses: Expense Reimbursement Fraud
This training program will address why internal controls over travel and entertainment (T&E) expenditures are a critical component of the control environment. Although the topic of travel and entertainment abuse is not one that management likes to address, it is a very important indicator of the adequacy of a company's control environment.

Carolyn Troiano Tuesday, November 27, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - 21 CFR Part 11 - Guidance for Electronic Records and Electronic Signatures used in FDA-Regulated Computer Systems
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. This includes development of a company philosophy and approach and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

Dennis Taylor Tuesday, November 27, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dennis Taylor
Excel Formulas and Functions
Built in to Excel are over 450 functions - a potent set of power tools that simplifies certain kinds of formulas and gives you a huge number of computational possibilities. Many Excel functions provide extended analytical capabilities and open the door to more efficient use of Excel.

Jerry Lanese Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
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.

Rayleen M. Pirnie Wednesday, November 28, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Cyber Incident Response Plans: Planning for the Inevitable
This webinar training analyzes critical components of a Cyber Incident Response Plan and provides recommendations on how to prepare all staff for the inevitable situations. From internal considerations to your external solution providers, get a realistic view of how a cyber-attack can quickly spiral a typical day into complete chaos and cause significant losses without preparation.

Dr. Shuguang Huang Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Dr. Shuguang Huang
Statistics in Non-Clinical Development
In this webinar, I will give an overview of the use of statistics in different non-clinical fields, which mainly include

Susanne Manz Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Susanne Manz
Addressing CAPA within a Device Quality System
This webinar will help you ensure an efficient and effective CAPA process leading to improved quality and compliance for your company. You’ll learn how to streamline and monitor your process to ensure compliance and improved performance. If your CAPA process needs a CAPA this webinar is for you.

Ginette Collazo Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Ginette Collazo
Controlling Human Error in the Manufacturing Floor
Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

Dr. Subodh Bhardwaj Thursday, November 29, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Dr. Subodh Bhardwaj
Current challenges in Vaccine Pharmacovigilance and Risk Mitigation Strategies
This topic covers all the possible factors responsible for monitoring adverse events (AEs) to vaccines of different manufacturers, routes of administration and strains. The pitfalls of new technologies in vaccine production and their impact on effective PV. How to be compliant and accurate in SAE detection and assessment, management.

Shep Bentley Friday, November 30, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Shep Bentley
3-Hour Virtual Seminar on Medical Device Single Audit Program (MDSAP) Preparation
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a work group to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).

Danielle DeLucy Friday, November 30, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Danielle DeLucy
Handling OOS Test Results and Completing Robust Investigations
This training program will provide participants with a This training program will describe when a full investigation should be triggered and the frequency for re-testing and re-sampling. Attendees will also learn how to implement corrective and preventive action plans (CAPA).

Laura Brown Friday, November 30, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Audit Against ICH GCP 2 Addendum to Ensure Compliance
It is important GCP Auditors to understand how to audit the changes required by the new ICH GCP R2 Addendum. To consider how audit checklists and procedures should have been updated to ensure the new requirements are met and their organisations are ready for regulatory inspection. The session will also include an update on the proposed further major revision of ICH GCP R2 planned by ICH to start later next year. The new guideline includes a number of "hot" GCP inspection topics which are also covered in a number of other EU and FDA guidelines and documents, such as risk-based approaches for running clinical trials. These new approaches are going to be areas inspectors will be focussing on.

Laura Brown Wednesday, December 5, 2018
10:00 AM PST | 01:00 PM EST
Duration:60 Minutes
Price: ¤150.00
by: Laura Brown
How to Demonstrate Vendor-CRO-CMO Oversight in the Biopharma and Device Industry
This webinar is specifically designed for sponsoring biopharma and device companies who are outsourcing.It will help you get to grips with effective Vendors (including CRO,CMO, and other vendors) management used in the biopharma and device industries and your responsibilities as the sponsor.

Emil W Ciurczak Friday, December 7, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Emil W Ciurczak
Theory and Practice of Near-Infrared Spectroscopy (NIRS)
NIR is more complex than typical spectroscopic methods. This webinar will compare and contrast NIRS with "commonly used" spectrometers, now in use and more familiar to analysts.

Carolyn Troiano Friday, December 7, 2018
09:00 AM PST | 12:00 PM EST
Duration:3 Hours
Price: ¤290.00
by: Carolyn Troiano
3-Hour Virtual Seminar - Best Practices to Help you Pass an FDA Computer System Validation Audit
FDA requires that all computer systems used to produce, manage and report on "GxP" (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.

Rayleen M. Pirnie Tuesday, December 11, 2018
10:00 AM PST | 01:00 PM EST
Duration:90 Minutes
Price: ¤150.00
by: Rayleen M. Pirnie
Handling Situations Where Regulation E and ACH Don't Align
This training program will review intent and focus of Regulation E and the ACH Rules.It will analyze situations where Regulation E and the ACH Rules do not align and help determine appropriate responses and procedures to manage risk and loss.

  • Miles Hutchinson Recorded
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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 Dills Recorded
    View Anytime
    Price: ¤189.00
    by: David 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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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 Dills Recorded
    View Anytime
    Price: ¤189.00
    by: David 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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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 Dills Recorded
    View Anytime
    Price: ¤189.00
    by: David 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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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 Dills Recorded
    View Anytime
    Price: ¤189.00
    by: David 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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    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.

  • Erin Hallenberg Recorded
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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 Dills Recorded
    View Anytime
    Price: ¤189.00
    by: David 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 Dills Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤189.00
    by: David 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 Dills Recorded
    View Anytime
    Duration:3 Hours
    Price: ¤189.00
    by: David 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 Dills Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤189.00
    by: David 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 Dills Recorded
    View Anytime
    Duration:90 Minutes
    Price: ¤139.00
    by: David 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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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
    View Anytime
    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.