To Facilitate a Closed-Loop Problem Resolution System

Published 1 month ago by COMPLIANCE4ALL on EDUCATION 156 Views
Defined Failure Investigation and Root Cause Analysis is a major tool in

product complaint, non-conformance, and OOS failure investigations.

Why should you Attend:
Expectations for meaningful CAPA, supported by results-driven Failure

Investigation and Root Cause Analysis, that addresses and resolves

underlying product problems, are growing among regulatory agencies


Areas Covered in the Session:
Regulatory "Hot Buttons"
The 4 Basic Steps to Problem Solving
A Suggested Investigation Template
ID / Document the Problem - CAPA, et al

Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements

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: [email protected]