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WorldTraining

To Facilitate a Closed-Loop Problem Resolution System


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Who should attend?

Engineering Production Operations Consultants

Details

Overview:
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
world-wide.

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
QA
RA
R&D
Engineering
Production
Operations

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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

Prices

One Dial-in One Attendee Price: $150.00

Contact

Event Manager
support@compliance4all.com

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