Device Changes, FDA Changes, and the 510(k)-2019
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Website https://www.compliance4all.com/control/w_product/~product_id=502271LIVE?channel=ourglocal_Mar_2019_S |
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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
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 / rationaleResolving a "wrong decision"Who Will Benefit:Senior Management, Project Leaders, Internal / External ConsultantsRegulatory AffairsQuality Systems Personnel / QAER&D and Engineering StaffSpeaker 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$150.00Contact Detail:Compliance4All DBA NetZealous,Phone: +1-800-447-9407Email: compliance4all14gmail.com
Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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