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Device Changes, FDA Changes, and the 510(k)-2019
Presented By Netzealous LLC DBA - Compliance4All
Wednesday, March 20th at 10:00am PST
Online sale ends: 03/19/19 at 10:00pm PST
Online
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539
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Talent
Description
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 Additional Information
One Dial-in One Attendee
Price: $150.00
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Presented By
10:00am to 11:00am
General Admission: $150.00
All Ages
50 18004479407 UPCOMING EVENTS
PAST EVENTS
Wednesday, January 16th
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Tuesday, January 15th
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