To Facilitate a Closed-Loop Problem Resolution System

Fremont, CA
Root Cause Analysis, CAPA Courses, Device Risk Management, Biologics, Dietary Supplements, Failure Investigation, product risk management"

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

Schedule of Presentations:

Wednesday, January 17, 2018
3D Tissue Models
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