Device Changes, FDA Changes, and the 510(k)-2019
Added by Compliance4all on 2019-01-17
Conference Dates:
Start Date: 2019-03-20Conference Contact Info:
Contact Person: Event ManagerEmail: [email protected]
Address: 161 Mission Falls Lane, Suite 216,, Fremont, California, 94539, United States
Tel: 18004479407
Fax: 302-288-6884
Conference Description:
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]