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Device Changes, FDA Changes, and the 510(k)-2019
This Webinar is over| Date | Mar 20, 2019 |
| Time | 01:00 PM EDT |
| Cost | $150.00 |
|
Online
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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
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
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