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Site language : English - Français
Ref : 26170
Event :To Facilitate a Closed-Loop Problem Resolution System

Date :Wednesday January 17th, 2018

Location :Online (Internet, Videoconferencing, ...)

Type :Education - International audience

Accreditation :--


 

Further information

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

Further information

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Announcer

Compliance4All
Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. . Compliance4All [...]

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Presentation sheet from Compliance4All

Details

To Facilitate a Closed-Loop Problem Resolution System Medicine - Management - Pharmacy
" root cause analysis, capa courses, device risk management, biologics, dietary supplements, failure investigation, product risk management"
Professionals, Engineering Production Operations Consultants
100 1 --
English

Other

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