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

View: 97

Website | Edit Freely

Category product development, Regulatory Submissions, Engineering Staff

Deadline: March 19, 2019 | Date: March 20, 2019

Venue/Country: Online, U.S.A

Updated: 2019-01-21 15:12:23 (GMT+9)

Call For Papers - CFP


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


Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.