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

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online Fremont, CA 94539  
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Start:   Wednesday, March 20, 2019  10:00 AM
End:   Wednesday, March 20, 2019  11:00 AM

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Event Features: Educational, Lecture, Special Event

Neighborhood: South Philly


       



https://www.compliance4all.com/control/w...


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: compliance4all14@gmail.com

Link To This Page (click to send to friends!): https://www.UpcomingEvents.com/event/38186/

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