This course explores the deviation and CAPA processes and best practices for both. It shows how to avoid pitfalls and minimize regulatory scrutiny by having a robust deviation/CAPA system and thorough investigations.
Why you should attend:
The attendee will learn the best practices for the deviation process and the important points from a regulatory standpoint.
Areas Covered In the Session:
Explores typical deviation and CAPA processes within the Quality System
Explores best practices for the deviation and CAPA processes
Explores best practices for documentation
Who will benefit:
John R. Godshalk currently works for the Biologics Consulting Group as a Senior Consultant. John served as a Senior Review Biochemical Engineer and Lead cGMP inspector in the Division of Manufacturing and Product Quality at CBER, FDA. He contributed to formulation of FDA policy.