Pre-Control is easier than SPC! With no control limits to calculate and go/no go colored zones, this control tool can rapidly help to reduce process variation. Participants will observe a modeled session that both develops and runs a Pre-Control chart.
Many medical device companies are surprised when they have a recall, a 483, warning letter or even a consent decree. Yet, all medical device companies follow the same regulatory requirements.So why are some companies more successful than others in terms of quality and compliance? This webinar will explore the seven capabilities every company needs to master in order to succeed in the future. We'll discuss how to evaluate yourself and develop plans to improve your capabilities. You'll learn how to use maturity modeling to develop your Quality and Compliance Strategy.
Data quality and compliance to a required level of performance are measured by statistical tools. Usually in compliance there is a very heavy weighing towards only 3-sigma deviations. But statistics gives much more than that. There are other signs that being "out of control" is a building situation. These other statistical patterns can be used to trigger preventive actions without the dire consequence of a non-compliance.
Using formulas turns Excel into the world's most powerful calculator. Whether you need to calculate loan repayments, generate a profit and loss account, solve maths or engineering problems, in fact, think of any scenario that involves addition, subtraction, division or multiplication of numbers and you'll find that Excel is the best tool for the job.
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.
Computer System Validation is an area foreign to most capital projects Project Managers. This webinar will present REAL WORLD lessons learned from the management of dozens of projects in the area of Pharmaceutical Manufacturing Facility construction. A detailed description of a typical requirements will be presented, but more importantly, this webinar will address what that means to a Project Manager and the Project Team. It will give introduction to critical issues and discuss and present case study lessons learned.
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). Computer software was in a state of infancy during the 1970's and the role computer software would eventually play in the provision of healthcare was not foreseen.
Financial institutions have long been the payments engines for their customers. However, with heightened competition and the advent of new non-bank entries into the marketplace, financial institutions have been playing more defense than offense. It is now time to go from playing 'not to lose' to using the implied trust and the customer experience to reverse the trend, get back lost customers,and retain existing ones.
Just as a manufacturing process produces a product, controlled documents are the product of a business process. Just as in manufacturing, a product cannot move forward if it is waiting for component parts, a document cannot move forward if it is waiting for information, or if its use is constrained by other documents. Although many life science companies advocate lean manufacturing, lean laboratory, and lean operations, they have cumbersome controlled documents and systems which cause significant operating expenses, and make it difficult to introduce process improvements in a timely manner.
This training is designed to help process plant management teams be prepared to address major applicable environmental protection programs. Storm water run-off during rain events can affect wetlands close to and very distant from a facility. Management teams must understand the components of storm water permits. We will discuss the permit itself and what makes up a Storm Water Pollution Prevention Plan (SWPPP). Further, the webinar will highlight key distinguishable categories of an air quality permit with regard to noxious emissions. Considerable time detailing the major differences between major and minor generators. Finally, we will give name, description and often overlooked aspects of waste handling. We will discuss major storage and transport requirements of special waste, universal waste, e-Waste, and hazardous materials Often these programs and their administration records are put to the test by third party auditors who are representing regulatory agencies.
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.
Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify, test and document.
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.
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flow on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics..
This course explores some of the best practices of pharmaceutical facility design with an emphasis on regulatory aspects. FDA and other global regulatory body requirements are discussed and the reasoning behind them.
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".
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.
Accelerated aging (AA) is testing that uses aggravated conditions of heat, oxygen, sunlight, vibration, chemicals, etc. to speed up the normal aging processes of items. It is used to help determine the long-term effects of expected levels of stress within a shorter time, usually in a laboratory by controlled standard test methods.
Regulatory agencies conduct product-related GMP inspections when assessing an application for marketing approval. This inspection checks if the manufacturer complies with GMP principles and practices from ICH and the local region. Product-related inspections may also be conducted if the agency is informed or suspects a possible GMP breach.
This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Japan. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Japan. Content will also include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.
Many companies use attribute sampling plans at incoming, in-process, and final inspection. However, variables sampling plans based on ANSI/ASQ Z1.9 can reduce cost by requiring smaller sample sizes. Z1.9 looks complicated, because it was written before the advent of calculators. A simple statistical calculator eliminates the need for the long form manual calculations of the mean and standard deviation. Z1.9 uses information more effectively than an attribute sampling plan. An inspection operation that measures values and converts them to attributes looses information. As a result, the attribute sample size is larger to compensate. Using the measured values directly can reduce sample size and help lower cost. A calculator or spreadsheet makes the standard easy to implement.
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.
This course will help participants examine issues on the project from multiple viewpoints. While a General Contractor certainly has one perspective on the project, so too do the Owner, Architect/Engineer, Subcontractors, and other Stakeholders. By learning to present issues in the right framework we decrease adversarial behaviors on the project and increase the likelihood that our proposals for additional work will be accepted.
At the completion of this course you will have the tools necessary to evaluate the W9 and prepare a Form 1099-MISC with all the blocks properly completed. This course will cover not only these common mistakes but make suggestions regarding the contents of each Block on the Form 1099-MISC.
If you are constantly struggling to create, manage, and maintain all of the information found in Design Inputs, Design Outputs, and traceability matrices, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.
Every business that purchases and contracts for goods or services is vulnerable to a wide variety of fraud hazards. Many of the fraud schemes involve vendors and contractors in collusion with employees responsible for making purchases and administrating contracts, as well as with the employee who requests the purchase of goods or services. Other fraud hazards involve solicited and bidding contractors in collusion with each other. Most procurement frauds go undetected due to the off the books nature of the fraud. The ACFE suggests that organizations lose as much as 5% of revenue to fraud. Government Agencies have armies of investigators and auditors whose mission is to prevent and detect procurement and contract fraud. Small, medium, and even large businesses are often not equipped to combat this prevalent vulnerability. The first step is awareness of the hazard.
According to the US GMPS "The suitability of all testing methods shall be verified under actual conditions of use". This is supported by the USP, which states "Users of compendial analytical procedures are not required to validate these procedures when first used in their laboratories, but documented evidence of suitability should be established under actual conditions of use." A modified definition of the accepted definition of test method validation "Documented evidence that the test method performs as intended in the using laboratory" supports the concept of method verification. It is clear that when a test method is moved into any laboratory that has not performed the test before the firm must do something to demonstrate that the test method performs as intended. The transfer could be from the method development laboratory to the internal Quality Control testing laboratory or a laboratory supporting a contract manufacturer. The firm must demonstrate that the receiving laboratory is capable of performing the test and that the test results accurately reflect the attribute being tested.
This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their probability.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?
This webinar will explain the procedure described in ISO62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success criteria is qualitative rather than quantitative as is in device validation. Claiming success because eg. 95% of test participants did not commit a user error is not valid. Nor is 100% positive test results sufficient.
This training will explain the main principles behind a QbD approach and provide guidelines in how to implement the concepts into a pharmaceutical development organization. Topics covered will include the target product quality profile, risk assessment, methods to establish a design space, and design of a control strategy. This review will help bridge the gap between understanding the principles and practical application.
Excel expert David Ringstrom, CPA, shows you how to implement internal control features within your Excel spreadsheets in this enlightening presentation. David uses a simple invoice form as a teaching aid to present various ways to control users' actions within Excel spreadsheets and to protect worksheets and workbooks from unauthorized changes. David demonstrates every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. He'll draw to your attention any differences in Excel 2013, 2010, or 2007 during the presentation as well as in his detailed handouts. David also provides an Excel workbook that includes most of the examples he uses during the webcast.
The records in a lab - the logbooks for chemicals,reagent and calibration solutions, for sample preparation, for instrument maintenance and calibration, for quality checks - all are time oriented. This gives window of cause-and-effect or coincidence that can give clues. The sum of these, plus the symptoms of the non-compliance can point out the likely root cause.
This session will include the requirements for defining, documenting, and implementing a complaint-handling system, including the requirements for complaint review, investigation, and corrective action, as well as the ISO-specific implications. Also, discussed will be the best way to document customer feedback, what constitutes a complaint, and what do with "non-complaint" feedback. Also contained will be a suggested method on including complaint trending into your firm's CAPA program. Additionally, the application of risk management to a complaint handling system will be reviewed, and a specific risk management system explained.
A high number of complaints may suggest your business customer is engaging in Unfair, Deceptive or Abusive Acts and Practices (UDAAP). Harmful businesses don't disclose a poor or declining reputation, yet this can signal that your business customer is engaged in anti-consumer behavior.
ACH Returns can be complicated and requires attention to detail. In the ACH network, for years, returns have been sent- typically with financial institutions processing exception items on Day 2 why not change that now in the new Same Day ACH environment? There are many opportunities with the extra settlement windows for exception processing to change (if the RDFI wants to)- this session will identify the options and it's up to the participant whether they will utilize the option or not.
In the highly regulated medical device industry, management responsibility and management review are critical concepts in ensuring a suitable Quality Management System (QMS). It is critical that management establishes a quality policy, quality objectives, and provides adequate resources. However, management often fails to realize the importance of their role with respect to quality. In this course, we'll discuss how to improve awareness, focus, and a culture of quality. We'll discuss how you can keep management aware and informed. We'll discuss "red flags" or warning signs of problems.
The webinar will provide important considerations when selecting sample sizes for specific applications. The knowledge gained by attending the webinar will allow practitioners to consider the implications of sample size selection prior to conducting the study and ensure that the information obtained can be useful for decision making.
In this webinar, you'll learn about the common types of fraud perpetrated against organizations and how to implement processes, procedures, and controls that mitigate your risk.You'll learn about a number of different fraud schemes, focusing on fraud committed against small businesses.
In this presentation will cover the requirement for management review from FDA cGMP and ISO 13485 and approaches that can make these effective. Management review should be a key part of keeping your quality management system efficient and effective. It will cover how to get the attention of your senior management as well as practical advice on efficient methods for conducting and documenting management reviews.
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.
This training is designed to help process plant management teams work together to prevent and eliminate risk to food safety. The FDA has a legislative mandate to require comprehensive, science-based preventive controls across the nation's food supply.Food facilities are required to implement a written Hazard Analysis and Risk-based Preventive Controls (HARPC) plan. This coms by way of a five step approach
Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components will be provided. Engineering schematics will also be included. All component functions will be detailed with recommendations as to which component type is considered optimal.
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. Procedures play a vital role in human reliability. Nevertheless, it is really important to understand human behavior and the psychology of error as well as understand exactly where the instructions weaknesses are, so procedures can be human engineered, improved and/or fixed.
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.
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".
Computer Intrusions are the cyber actor's portal to invade and burglarize homes and business across the nation and the threat will only continue to grow. The Financial Industry is faced with increasingly complex threats almost daily. These threats challenge traditional models of law enforcement, IT Management and Regulations. The SEC's Cyber Sweep Exam is not only another regulatory task for Financial Advisors but also serves as an outline to help your firm defend against the Cyber Criminal. Education, awareness and communication will help defend against the criminal element and protect our clients and our firms. The ongoing impact to financial firms is of critical importance to all. We hope this session will help educate you on your role in the defense process as well as review the regulatory landscape surrounding this topic.
Business Administration is often very generalized and even more often overlooked by project managers. This course is targeted to teach you the strategic and business administration concepts that are specific to project management.
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.
Review of basic polymer chemistry and changes in polymer characteristics can be anticipated and designed for. Learn how to plan for post radiation resistance and lifetime functionality. All radiation modalities (gamma, e-beam, x-ray) will be reviewed for a basic understanding of the sterilization process and the influences that product design and assembly can have on success.
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.
This webinar session will explore the importance of controlling losses for a retail business to be successful. A business owner must understand that controlling losses is just as important as controlling sales and costs. Controlling losses is often the area that is overlooked, which leads to many small business retail failures. It is important that business owners Understanding what causes losses, formulate and implement loss prevention policies and procedures, audit and compare practices to established procedures, and learn how to conduct a Shrink Investigation when the source of losses are not identified.
This webinar will introduce and overview the concept of containing compliance costs - working smart. The webinar will provide a comprehensive strategy for cost reduction in regulatory affairs and compliance by presenting strategies for complying with FDA regulations in a cost-effective manner. These strategies include:
Excel® Applications are widely used in laboratories, offices and manufacturing e.g for data capture, data evaluation and report generation. Regulations such as FDA'sGxPs and 21 CFR Part 11 require users of software and computer systems to demonstrate and document data accuracy, integrity and confidentiality. Out-of-the box Excel® has not been designed for regulated environments. However, with a good knowledge of Excel® capabilities combined with good procedures and practices on how to control, validate and use Excel® requirements can be met. Attendees of this webinar will get all details on how requirements can be met.
In this webinar you will learn the different global agencies expectations of analytical equipment qualification along with the development of a sound process validation program in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system.
A lack of adequate control over purchases has resulted in a significant number of recalls due to component failures. Since FDA does not directly 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. Most medical device manufacturers have acceptable systems in place to assure component quality. But what about supplier quality? Your company must have procedures in place that describe the methods you use to evaluate potential suppliers, and set forth requirements that your suppliers must meet to be considered 'approved.' You must also have a system in place to routinely assess your suppliers, and set forth the applicable criteria they must meet to remain 'approved.' You may never have to pay a visit to your supplier if you have a good supplier control program in place.
This class is designed to give you the basics for doing an operational audit. We will discuss management and audit concepts to help you understand how the process works. We will also do some exercises to further strengthen your knowledge.
If you're like millions of other business professionals, you probably use Microsoft Outlook every day to manage your email, calendar and to do's. It's available for Windows, Mac, mobile and there's even a web version. So there's no excuse not to be organised. Or so the theory goes. The reality is email overload, missed deadlines and calendars so full you have no room to breathe
The information obtained will enable effectiveness and reliability of a review process for all materials.The webinar will address requirements for compliance within the US, "gray areas" that must be evaluated thoroughly, how to conduct a risk assessment,strategies for mitigating risks and making challenging decision. You will hear about the opportunities for input from regulatory agencies at critical stages and on key promotional materials and you will hear strategies for implementing review process and procedures to facilitate high compliance standards.
This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
Learn that treating your patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs form unnecessary surgeries and faster rehabilitation. However one must know how to get the proper licensure and know the Federal & State Guidelines. You must know how to prepare to deal with the insurance companies that constantly deny every claim they can for any reason possible.
Excel expert David Ringstrom, CPA, will share helpful tweaks you can use with the revered VLOOKUP function in this valuable webcast. VLOOKUP is the lookup function many users rely on to return data from other locations in a worksheet. However, using VLOOKUP isn't always the most efficient approach, so David will explain alternatives, including the INDEX and MATCH, SUMIF, SUMIFS, SUMPRODUCT, IFNA, and OFFSET functions.
Instrumental liquid chromatography is an analysis are widely used to determine purity, the impurities, and the degradation products of pharmaceuticals. The focus of most validation work is on the methodology, the standard operating procedure (SOP). But validation of the instrumentation and other associated items of column, solvents, and other reagents and chemicals is also an area of focus in an audit.
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. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and tools to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
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.
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.
This webinar will explain the concept of International ACH, how it works, rationale for choosing it and how it differs from US domestic ACH. It will also discuss what the International Payments Framework Association (IPFA) is and how it addresses International ACH issues. Instructor will cover customer benefits and value proposition regarding International ACH and why it may be preferred over wire transfers.
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
This training will introduce the concepts associated with implementing a carefully defined technical and business governance programs along with clearly defined R&D to site transfer steps for successful implementation. It will cover the concepts associated with transferring the scientific technology needed to manufacture the product, processes to ensure the receiving manufacturing facility is ready for the product and tools and templates to help capture the knowledge.
Design Control is considered a critical process by the FDA. Yet is still a common source of 483 and Warning Letter observations. Most importantly, Design Control is critical to product quality, ensuring safe and effective products for your customers. This 90-minute webinar will cover the basics of design controls for medical devices. Design Controls are an integrated set of management practices that are customer focused and ensure quality and consistency. This webinar can help you create a design control process that is a competitive strength for your company.
Complaint Labelling of various product types can be very challenging. Companies working with a wide range of products must ensure that their labels are compliant. This session covers the regulatory requirements of various product types including:
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company's CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with. Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.
DTC may be deemed as misbranding your product and, therefore, may not be marketed. Firms must be more sophisticated now in designing their advertising methods and messages. The days of looking at text alone for a magazine insert are long gone. You should pay attention to the components of your advertising in mass media, such as volume; images; information prominence and conspicuousness; speed of the message subliminal messaging and "the take away message." This means you need to understand what each component of the advertising attempts to accomplish and then evaluate the integrated message, i.e., the "take away." The difficulty is that this broad horizon of factors gives the FDA abundant opportunities to say that you have misbranded your product. Hence, it is illegal.
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.
Early clinical trials are conducted to establish initial safety of a drug. The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.
OneNote is a digital notebook. It is available for Windows, Mac and mobile. Use it to capture, store and organise your ideas and information. OneNote notes can store text, images, videos, embedded files and even drawings and sketches. OneNote notebooks can be shared with colleagues and customers, in fact anyone, making it the perfect platform for collaborative work. Use OneNote to manage your projects. Use OneNote to manage your meetings. Use OneNote to manage your life.
Information management is a discipline that continues to evolve. Before 1990 organizations primarily recorded their research, development and business information on paper. Over the next 25+ years computers have increasing been involved in authoring and the incidence of paper records has decreased exponentially.
This training is designed to help process plant management teams be prepared to answer questions about quality assurance and control across multiple disciplines. The maintenance manager, quality manager, and production manager must see these requirements through a common lens provided by the governing bodies. Often these process controls and their records are put to the test by third party auditors who are representing the global food safety perspective.
No one disputes the importance of proper training for all employees in a medical device company. Yet defining needs for all employees, either individually or by position description, can be a real challenge. This is especially true for start-up and other small medical device companies, or rapidly growing companies. Specific FDA training requirements will be presented. Techniques for needs assessment and record keeping will focus on in-house training while also covering how experience and outside training can be integrated into this training. Although this presentation will focus on what works for small and medium sized companies, the principles are equally applicable to larger companies.
This presentation explains the requirements for control of inspection, measuring, and test equipment. This includes a calibration program that satisfies FDA's Quality System Regulation (QSR), ISO 13485:2003, and ISO 13485:2016. The presentation defines accuracy, precision, and traceability. After explaining the concepts, it moves to an analysis of the requirements from each of the quality management standards. Implementing these requirements requires attention to detail, accurate records, and effective systems. Manufacturers must understand the requirements so they can develop and implement effective processes and procedures. In addition to the specific requirements, the presentation includes examples from FDA Warning Letters, information from FDA's Quality System Inspection Technique (QSIT), and the Medical Device Single Audit Program (MDSAP) Audit Model.
If you are looking for ways to improve your Corporate Expense Account Oversight and Reporting, you will find best-of-breed practices and suggestions at a basic level. Finance and Operational staff will find this presentation interesting and informative. This webinar will provide you with some of the best practices in corporate expense account review used today.
Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR) are key building blocks used in the design, development, manufacturing, and cGMP compliance for the Medical Device Industry. Too often, these are cluttered, confusing, and cause many errors due to the way they are created, organized, and managed.
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. For a long time there was no official guidance on what exactly is expected to maintain 'the validated state'. Now the USP has published an updated general chapter <1224>. Also the FDA has released an official guidance on how to conduct and document method transfer. In addition the FDA has included requirements for method transfer in its new guidance from 2015 on validation of analytical methods. And last but not least Europe has released an updated GMP Chapter 6 with clear requirements for comparative testing and acceptance criteria. This seminar will give a good understanding of USP, FDA and EU requirements and provide recommendations and tools for effective implementation.
The FDA in 2011 instituted its latest interpretation. Many have not chosen to take it seriously or change their business model. The paradigm has shifted and this presentation will articulate what has changed and how we need to react. Validation as derived from industry practice has a new spin. This presentation will take you through that development and demonstrate how some in the industry have reacted to the new expectations.
This webinar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe and effective products to your customers. Learn how to prevent quality and compliance problems by having a strong system for Purchasing Controls This webinar will help you to understand the regulations and how you can translate them into an efficient and effective process for purchasing/ supplier control.
The Food and Drug Administration (FDA) was not empowered by Congress to regulate medical devices until May 28, 1976 when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA).
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.
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.
This webinar will review the key concepts behind Design of Experiments. A strategy for utilizing sequential experiments to most efficiently understand and model a process is presented. Many common types of experiments and their applications are presented. These include experiments appropriate for screening, optimization, mixtures/formulations, etc. Several important techniques in experimental design (such as replication, blocking, and randomization) are introduced. A Case Study involving optimizing a manufacturing process with multiple responses is presented.
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.
Can a Doctor of Chiropractic really bill Medicare for DME? It is not if but how. Explore the strategies to be able to provide your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs by preventing unnecessary surgeries. Learn how to get the proper licensure and how to be compliant with all Federal & State Guidelines.
This webinar explains the logic behind sample-size choice for several statistical methods that are commonly used in verification or validation efforts, and how to express a valid statistical justification for a chosen sample size.
FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use.
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording. This 60 min Webinar will discuss the proper timing and wording to use for the 483 response to put your company in the best position with the FDA. FDA policy and goals regarding the 483 response are discussed. Examples of both good and poor responses are given. Warning Letters and responses are discussed and the implications of both a good and poor response to a possible Warning Letter are given. The standard format of the 483 response is given along with an explanation there of.
This workshop will explore what SOPs are, what they are used for, when they are required, how to write them effectively for compliance and for implementation within the organization, and how to ensure effective communication and training of procedures within the SOPs.
Excel expert David H. Ringstrom, CPA, draws your attention to the What-If Analysis tools available within Excel's Data menu in this informative presentation. David teaches you how and when to make use of Excel's Scenario Manager as well as how to use the Data Table feature to compare calculation results based on two or three inputs. He also explains how Excel's Goal Seek feature empowers you to perform basic what-if analyses, in effect, solving for a single value.
This course will teach how to conduct a software validation program that will satisfy FDA requirements and produce a safe product. We will explain the role of risk analysis in validation. How software requirements are used in validation will be described. This course is NOT a programming course. We will discuss what must be done but will not discuss methods to execute necessary testing.
This webinar will explore how to improve your internal audit program so it is the efficient and effective tool it is meant to be. Internal Audit is a required part of an effective quality system. More importantly, it is an incredibly powerful tool to identify areas of non-compliance. A well-designed audit program can be an effective tool in understanding, communicating, and reducing compliance risk.
Learn how to provide your Medicare patients with Durable Medical Equipment to maximize patient clinical outcomes while developing a great revenue stream. The key is how to be legally compliant. Understand the process in how to get the proper licensure called DME PAN # and know the Federal & State Guidelines.
In this presentation you will learn the importance of root cause analysis and how it fits into an effective corrective and preventive action system. There will be a review of the principles of Corrective and Preventive Action. Risk Management is a current FDA hot topic, and Root cause analysis and Risk Management are intimately connected, and using risk management principles while doing root cause analysis is not only smart but cost effective. We will also cover where else in your quality management system root-cause analysis can be used. Learn how Root cause analysis can be used in process control.
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. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Year after year, CAPA is the subsystem cited most frequently during FDA inspections. 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, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.
The FDA and U.S. Customs and Border Protection are using new import requirements. The FDA's import software screening program (PREDICT) and the U.S. Custom's ACE software program require more information from the foreign source(s). FDA's product codes and U.S. Harmonized Tariff Schedule (HTS) link the requirements. The software coding information must be correct. Otherwise, you face costly delays and possibly a refusal of the entry. In addition, information on the entry's commercial or pro forma invoice must be consistent with the information entered into PREDICT and ACE software. FDA offers some relief from the strict requirements if you participate in a voluntary Affirmation of Compliance (AOC). Providing accurate information is necessary in order to reconcile the PREDICD, ACE, Invoice and AOC information. Your failure to accomplish these tasks can lead to smooth sailing or to a whirlpool of costly delays and fines. Time is not on your side during the import process. Time is money; the more you use, the more you lose.
This webinar will address approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
Learn that treating your Medicare patients with Durable Medical Equipment can be great for patient clinical outcomes, a great revenue stream and can be legally compliant. It will also lower healthcare costs. However one must know how to get the proper licensure and know the Federal & State Guidelines.
VBA is the programming language that is built in to Excel (and the other applications in the MS Office Suite).VBA is used to automate tasks that would otherwise have to be performed manually by pressing keys and selecting items with the mouse-and if that sounds like a macro-well it is.
Learn from Excel expert David H. Ringstrom, CPA, how to create resilient and practical budget spreadsheets in this informative webcast. David shares a wide range of helpful techniques, including how to separate inputs from calculations, streamline formula writing, preserve key formulas, and create both operating and cash flow budgets. In addition, he explains the uses and benefits of a variety of Excel functions, including CHOOSE IFNA, IFERROR, and ISERROR ROUNDUP and ROUNDDOWN VLOOKUP and SUM and SUMIF.
The benefit of a consistent process is that the yield meets expected criteria. Firms that are able to implement such processes minimize their process rejections and therefore maximize profit. Domestic and international regulations actually assist in this endeavor, by setting forth the requirements to assure a process is consistent, and that it yields output that is both safe and effective. These requirements are applicable to both automated and manual processes. This webinar explains the regulatory requirements for process validation, and also includes definitions and application of applicable terminology, and hints and recommendation for the more common types of process validation. Also covered will be the validation technique used for processes that are already in place.
During this introductory session, delegates will gain a complete guide to the status and impact of the latest guidelines for combination products. Examples (company specific) of combination products will also be discussed to gain insights into their variety and complexities.
Written specifically for businesses, not-for-profits and government agencies, this 90-minute information packed course delves into the best practices every organization should implement to detect and mitigate the threat of ACH fraud. From internal controls and processes, to services you should discuss with your financial institution, this course helps any size organization reduce their exposure and risk. Regardless of how relentless the fraud is, so much of today's fraud losses can be avoided if you know what to look for and implement the right controls. The types of internal processes and controls necessary vary by industry and organization size. This course reviews a wide variety of options and recommendations to assist attendees with developing their own internal protocols.
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.
To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them. A complete and effective employee training program must be in place to assure this. This session will instruct attendees on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to verify training effectiveness, and how to document training so that it is readily available for review (by managers, auditors or inspectors).
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.
Cyber-attacks and breaches dominate the media and are a significant focus of the government. Businesses and financial institutions are faced with the grim reality that a cyber-attack is inevitable. It's not a matter of if an attack will occur, only when. Entities large and small are under siege by sophisticated attacks that often are financially driven, draining accounts as effectively as they cut off the entities operations. Incident Response Plans today have to consider a myriad of possible attack methods to ensure Plans appropriately mitigate unique threats.
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.