Overview: 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: Compliance Manager Process Engineer Production Manager Regulatory Manager Quality Manager Speaker Profile: 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. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]