Root Cause Analysis to Meet FDA Expectations - 2017

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 Solving
A Suggested Investigation Template

Who Will Benefit:

Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations

Speaker and Presenter Information

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.