Device Changes, FDA Changes, and the 510(k)-2019

Overview:

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

Regulatory Affairs

Quality Systems Personnel / QAE

R&D and Engineering Staff

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: compliance4all14@gmail.com

Speaker Profile:

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.