FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

This Internal Quality Audit training is presented as a practical way for an organization to evaluate its internal audit program and make required improvements.

A training package comprising three best-selling webinars that covers all aspects of the Physician Payment Sunshine Act, including the final rule, reporting and tracking requirements, how sponsors and investigators of clinical trials can comply and acceptable and unacceptable practices.

This training on auditing of software vendors for FDA compliance will explain the types of audit and its use in qualifying and selecting vendors. It will discuss sample forms and checklists which may be used by the participants for observations, recommendations and remediation.

Are you ready for the FDA to knock on your door? Although an effective Quality System should always be inspection-ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar can help you manage inspections efficiently and effectively. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.

This webinar will discuss the current status and outlook for federal oversight of Laboratory Developed Tests (LDTs) amid bureaucratic infighting during the COVID-19 pandemic regarding the authority of the Food & Drug Administration (FDA) to regulate LDTs.

Responding to the public’s ongoing concern about high and rising drug prices, the Biden Administration and 117th Congress with a fragile Democratic majority have unveiled key proposals to lower prescription drug costs.

This webinar will provide an overview of FDA and Health Canada, their organizational structure, regulatory and compliance oversight, agency interactions and implications for your organization and your regulatory and compliance obligations.

This SOP best practices webinar will show how to create “state of the art” SOP or review your current SOP so as to successfully manage FDA Investigators and other Regulatory Authorities Audits which can help improve and influence Audit Outcomes.

This Webinar will address the key elements on being an effective auditor for your company covering the different types of audits, what do audits measure and how are audit results measured and certainly why perform audits to begin with. Learn the basic skills required and how to apply them and the knowledge in becoming more effective.

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 essentials of design controls for medical devices.

This training on Software Development Standard IEC 62304 will provide you key insights on how to understand IEC 62304, and how to use the standard to help you uncover software related GMP violations.

The regulatory expectations for both pharmaceuticals and medical devices will be emphasized as well as overview of best practices for timely and effective investigations. This webinar will provide valuable assistance and guidance to the life sciences manufacturers engaged in various aspects of product complaint investigations.

This Design Control Inspection training will review of the sections of Quality system regulations, design control regulations which FDA uses as an inspection tool. Actual FDA investigator training methods related to design control inspections. Real life examples of FDA design control compliance issues will be examined.

This Webinar will highlight the requirements of ISO 17025 and ISO 34 and explain the preparation, testing of certified reference materials along with assessment of suppliers of reference materials.

AI/ ML will revolutionize medicine by making diagnosis and treatment more accessible and more effective. FDA has regulated medical software by means of regulation and guidance for years, however, AI/ML programs fall outside the scope of these regulations and guidance. This happens because the FDA approves the final, validated version of the software. The point of AI/ML is to learn and update the following deployment to improve performance. Thus, the field version of the software is no longer the validated approved version.

This webinar will provide an in-depth review of enforcement actions taken by the HHS OIG over the previous two months. We will also briefly review the Anti-Kickback Statute (“AKS”), discuss any new safe harbors, and OIG Advisory Opinions that have been issued.

This Quality inspection training will teaches tools and techniques that can be employed to get to the “root cause” of unexpected quality events, and to resolve them in a manner such that they stay resolved in a GMP compliant manner.

This system based inspection for Laboratory Control System training/webinar includes measures and activities related to laboratory procedures, testing, analytical methods development and validation or verification, and the stability program.

This FDA Inspection training will provide you an understanding of how the FDA conducts systems based inspections, and will review examples of FDA 483 observations, so you can better prepare for your PAI.

This Spreadsheet validation training will cover the use of spreadsheets to report data from the inception of the spreadsheet (user requirement specification), through the development process, validation, and use.