World Conference Calendar

34376 Conferences

To Facilitate a Closed-Loop Problem Resolution System

Added by Compliance4all on 2017-11-16

Conference Dates:

Start Date Start Date: 2018-01-17

Conference Contact Info:

Contact Person Contact Person: Event Manager
Email Email: support@compliance4All.com
Address Address: 161 Mission Falls Lane, Suite 216,, Fremont, CA, 94539, United States
Phone Tel: 18004479407
Phone Fax: 302-288-6884

Conference Description:

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.

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