Center for Professional Innovation & Education, Inc., Berlin, Germany
Dec. 4 & 5, 2013
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
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