FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

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.

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.

This FDA inspection training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

In this FDA audit & Inspection training we will focus on ideas that will help identify areas of improvement before the formal inspection occurs. Further, you will learn techniques that will enhance your effectiveness during the audit execution.

This FDA audit & inspection training will provide your firm with key insights on how to perform superior supplier audits. It will help you uncover purchasing controls GMP violations.

This FDA compliance training will provide valuable assistance to all new & existing OTC drug firms that are regulated by FDA due to their domestic USA sales.

This FDA compliance training will be valuable who are involved in the development of REMS and who are planning a submission and need to understand what might be required by FDA and how to comply and for those who have Risk Management Plans.

This 21 CFR Part 11 training will deliver concrete guidance which will provide a roadmap for compliance that will have immediate benefits, withstand FDA’s changes to Part 11, and discuss the new Obama administration approach to enforcement.

The FDA Audit inspection training defines the laboratory environment; points out problem areas and common pitfalls; and details solutions and also details how to prepare the Laboratory staff for an Inspection as well.

This FDA GMP (Good Manufacturing Practice) inspection training will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection.

This Cleaning validation training will provide valuable assistance to all regulated companies that need to develop and validate their equipment cleaning processes. This session will address risk-based approaches to cleaning validation studies using ICH Q9 and recent FDA comments and observations as a foundation. Recent FDA warning letters illustrate just how critical good cleaning practices are. Understanding and employing good cleaning practices are instrumental to improving cleaning consistency, quality and traceability. The FDA favors automated CIP systems since they reduce operator variability while enhancing consistency and reproducibility. Our research has indicated that in the last 5 years, cleaning citations were noted in 50% of warning FDA letters. Many cited contamination issues have an element of poor cleaning practices associated with them. Examples include “investigations…did not include an evaluation of the cleaning processes and procedures…to determine if equipment cleaning is effective in preventing cross contamination of the inactivated batches”, FDA Warning Letter, Jan 2008; "vaccine manufacturing plant in Pennsylvania, has been served with an FDA warning letter asking for measures to ensure batches of its flu shot ingredients do not become contaminated again.” Jul-2006..

An overview of ICH risk management techniques and how to apply them to equipment cleaning programs will be discussed. In addition, case studies from manufacturing facilities will be used to illustrate risk-based cleaning validation principles and practices.

This FDA compliance training will describe the essential requirements for producing sterile products in a practical, clear, concise manner that will facilitate its implementation.

This FDA Inspection training will examines the audit process and how to manage Process Deviation Investigations.

This Validation training will explain the intent and importance of process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This Process Validation training will detail the key qualification steps in process validation, the use of statistical methodology for sampling plans and acceptance criteria, how to handle deviations, elements of a good validation summary report. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This Validation training will explain the intent and importance of process validation, the connectivity between design control and process validation and the key pre-requisites and steps in process validation. Process validation is critical to the production of high quality, consistent, safe and effective products and devices. Routine end-product testing alone is insufficient to assure the quality, safety and effectiveness of a product or device. It is important that the product acceptance criteria and specifications are quantified, and that the manufacturing processes are well characterized, understood, controlled and validated.

This GLP (Good Laboratory Practices) webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. The GLP final study report represents the last chance for a study team to present their results in a clear and compelling manner. The report may also be a place where difficulties can be explained so that the study provides meaningful and trustworthy information. This webinar reviews the process of closing a study by preparing a final report and managing all records and specimens in a proper manner. It provides two areas of concentration: (1) the best practices in final report writing and (2) the step-by-step process of closing studies.

This FDA inspection training compiles the best practices now being used by many companies to host FDA inspections that will satisfy FDA inspectors and result in a good experience for the company. FDA inspections require a large amount of preparation and knowledge. Are you informed enough to avoid Warning Letters