FDA Inspections: What Regulators Expect and How to Prepare

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

*Approved by RAPS

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.