Center for Professional Innovation & Education, Inc., Malvern, PA
Mar. 17 & 18, 2014
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
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
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