Learn what approaches are required for product changes, for process changes, and Tracking and evaluating changes - the "tipping point" , and how is the process risk-based?
Areas Covered in the Session:
Is the process "risk based"?
K-97-1 and the FDA's "Decision Tree"
Documenting the process / rationale
Resolving a "wrong decision"
Who Will Benefit:
Senior Management, Project Leaders, Internal / External Consultants
Quality Systems Personnel / QAE
R&D and Engineering Staff
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses.
Event Fee: One Dial-in One Attendee Price: US$150.00
Compliance4All DBA NetZealous,