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. The deviation process is explored and evaluated and examples are given to demonstrate the best way to handle deviations and subsequent CAPAs. Attendees will have the opportunity to interact and ask questions about best practices regarding both devotions and the CAPA process. Reasons for having a robust deviation process are given with examples.
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
Tips on how to avoid possible pitfalls with deviations
Tips on minimizing regulatory scrutiny with deviations
Examples of good deviation write-ups, investigations and CAPAs
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. He has audited/inspected hundreds of pharma and biotech companies and reviewed processes and PV at these plants. John has provided advice to industry on regulatory strategies, pharmaceutical product facility design, best practices, and validation approaches that meet FDA licensing requirements. John received his B.S. in chemical engineering from N.C. State University and his M.S.E. in biochemical engineering from Johns Hopkins University.