This Event has Passed
Wednesday, March 20, 2019
10:00 AM - 11:00 AM
10:00 AM - 11:00 AM See all dates and Times
https://www.compliance4all.com/control/w_product/~product_id=502271LIVE?channel=upcomingevents_Mar_2019_SEO
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
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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
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
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.
Event Fee: One Dial-in One Attendee Price: US$150.00
Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]
