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

Date : 20th March 2019 to 20th March 2019

Place : United States, Fremont

Website :https://www.compliance4all.com/control/w_product/~product_id=502271LIVE?channel=allconferencealerts_Mar_2019_SEO

Contact Person:Event Manager

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: [email protected]

Device Changes, FDA Changes, and the 510(k)-2019 will be held in Fremont,United States on date 2019-03-20

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Deadline for abstracts/proposals : 18th March 2019

Keynote Speakers :

Venue :Fremont, CA, USA

Check the event website for more details.