This course is designed to provide participants with an understanding of the parameters, approaches, and concerns of FDA inspectors, and the tools for preparing, coping, and managing those inspections in pharmaceutical, biologics, and device facilities.
Additional benefits of this class include discussion of:
- FDA authority and process including 483s, Warning Letters, recalls, and other potential actions
- The FDA inspection process and approach
- Device Master Records requirements
- The use of a mock audit and outside certifying audit
- Required documentation, format, and archive
- How to respond to inspection and audit results
- Parallel process from the EMEA, TGA, PMDA, and other international regulatory agencies
- A chance to actively learn form fellow participants and well as from an instructor who brings 30 years of practical regulatory experience to a lively combination of lecture, discussion, and exercises
Who Should Attend
This is a practical, hands-on course designed to provide pharmaceutical, biopharmaceutical, biologics and medical device professionals with the information and tools they require to prepare for and manage an FDA inspection. The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance.
The course is designed to meet the objectives of preparing for – and surviving – an FDA inspection. Upon completion of the course you will:
- Understand the guidelines, philosophy and practical approach of the FDA to inspections and visits
- Understand the new FDA "systems approach" to inspections (QSIT), and the differences from the traditional "issues" approach
- Develop strategies for preparing for and coping with FDA inspections
- Plan for a self-audit in anticipation of FDA inspections
- Have resources for reference and update
Frequently Asked Questions
Is the class specific to pharmaceutical inspections?
Generally, the material is targeted to the pharmaceutical industry. However, the expectations for all FDA regulated industries (e.g. clinical, medical device) are covered.
Does the course include inspection of tobacco manufactures?
In that inspection regulations have not been adopted by the FDA, the instructor makes analogies to the tobacco industry throughout the course to assist such firms with inspection expectations.
I've attended other course on FDA inspections - telling me what my company needs to do. How is this course any different?
The instructor not only covers how companies need to prepare for an inspection, but also reviews (and reveals) how FDA inspectors prepare themselves to conduct an inspection.