Online Training by Compliance4all on Device Changes, FDA Changes, and the 510(k)

Website http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&A | Edit Freely

Category Senior management, project leaders, internal / external consultants

Deadline: January 24, 2017 | Date: January 25, 2017

Venue/Country: Online Event, U.S.A

Updated: 2016-11-09 14:15:08 (GMT+9)

Call For Papers - CFP

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Areas Covered in the Session:

U.S. FDA device clearance / approval

FDA's and EU's emphasis

Product changes and filing a new 510(k) - who's responsible

Tracking and evaluating changes - the "tipping point"

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. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: supportcompliance4All.com

http://www.compliance4all.com/

Event Link : http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&AdGroup=ourglocal_Jan_2017_SEO

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