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DTSTAMP:20240329T102728Z
UID:e43f0bb0-ba12-4b76-97e8-57becc5b1eae
DTSTART:20210118T100000
DTEND:20210119T100000
CLASS:PRIVATE
DESCRIPTION:Overview:
\nDefined Failure Investigation and Root Cause A
nalysis is a major tool in product complaint\, non-conformance\, and OOS f
ailure investigations.
\n
\nWhy should you Attend: \;
\
nExpectations for meaningful CAPA\, supported by results-driven Failure In
vestigation and Root Cause Analysis\, that addresses and resolves underlyi
ng product problems\, are growing among regulatory agencies world-wide.
\n
\nAreas Covered in the Session:
\nRegulatory "\;Hot Bu
ttons"\;
\nThe 4 Basic Steps to Problem Solving
\nA Suggeste
d Investigation Template
\nID / Document the Problem - CAPA\, et al\n
\nWho Will Benefit:
\nSenior management in Drugs\, Device
s\, Biologics\, Dietary Supplements
\nQA
\nRA
\nR&\;D
\nEngineering
\nProduction
\nOperations
\n
\nSpeake
r Profile:
\nJohn E. Lincoln is a medical device and regulatory affai
rs consultant. He has helped companies to implement or modify their GMP sy
stems and procedures\, product risk management\, U.S. FDA responses. In ad
dition\, he has successfully designed\, written and run all types of proce
ss\, equipment and software qualifications/validations\, which have passed
FDA audit or submission scrutiny\, and described in peer-reviewed technic
al articles\, and workshops\, world wide.
\n
\nContact Detail:\nCompliance4All DBA NetZealous\,
\nPhone: +1-800-447-9407
\
nEmail: support@compliance4All.com
SUMMARY:To Facilitate a Closed-Loop Problem Resolution System
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SUMMARY:To Facilitate a Closed-Loop Problem Resolution System
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