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Root Cause Analysis to Meet FDA Expectations - 2017

Start Date:
Wednesday, 24 May, 2017
End Date:
Wednesday, 24 May, 2017 11:00am
Business Practice, Health & Nutrition

Overview: Defined Failure Investigation and Root Cause Analysis is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities, the basic foundation of a viable CAPA system.Why should you Attend:A valid closed-loop CAPA system requires defined failure investigation including systemic root cause analysis for true problem (not symptom) resolution.

Growing high-profile field problems indicate that such effective and repeatable failure investigation and root cause analysis is still not the industry norm. Areas Covered in the Session:Regulatory "Hot Buttons" The 4 Basic Steps to Problem SolvingA Suggested Investigation TemplateWho Will Benefit:Senior management in Drugs, Devices, Biologics, Dietary Supplements QARAR&DEngineeringProductionOperationsSpeaker 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: +1-800-447-9407Email:


161 Mission Falls Lane,
Suite 216

Organizer Details

Conference organized by Compliance4ALL

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. .Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

161 Mission Falls Lane, Suite 216

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