The Most Serious FDA 483s - How to Avoid them

Date : 23rd April 2019 to 23rd April 2019

Place : United States, Fremont

Website :https://www.traininng.com/webinar/-200790live?channel=allconferencealerts-april_2019_SEO

Contact Person:Traininng.com LLC

Description:

This 90-minute session will provide valuable assistance to all regulated companies in evaluating their existing compliance and internal audit emphasis in light of the changed FDA focus based on recent 483 analysis, and their audit "paradigm". Such analysis allows a company to evaluate/ perform a gap analysis, and then put in place the necessary fixes to ensure continuing compliance.

The Most Serious FDA 483s - How to Avoid them will be held in Fremont,United States on date 2019-04-23

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Deadline for abstracts/proposals : 23rd April 2019

Keynote Speakers : 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. John has also managed pilot production, r

Conference Highlights :Recent Most Serious FDA 483s The "Whys" Root Causes Avoid complacency from past "good" FDA audits Shifting focus Maximize scarce resources The "risk-based" phased approach Maintain "the edge" - fight "entropy"

Venue :Fremont, CA, USA

Check the event website for more details.