Device Changes, FDA Changes, and the 510(k)-2019
Start Date: 2019-03-20
End Date: 2019-03-20
Time: 10:00 am to 11:00 am
Phone: (800) 447-9407
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,
Email: [email protected]
Organized by : Netzealous LLC DBA - Compliance4All Organizer's Address : 161 Mission Falls Lane, Suite 216, Tel : 800-447-9407 Mobile : 8004479407 Website : http://www.compliance4all.com/
About the Organizers :
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .
Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.