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DTSTAMP:20260411T000443Z
SUMMARY:Webinar on CAPA, Failure Investigation and Root Cause Analysis
  to Meet FDA Expectations
DESCRIPTION:Overview: Defined Failure Investigation and Root Cause Ana
 lysis is a major tool in product complaint, non-conformance, and OOS f
 ailure investigations, and hazard analysis / risk management and mitig
 ation activities, the basic foundation of a viable CAPA system.It is r
 equired in resolving verification and validation issues including data
  outliers that frequently but are often improperly dismissed arbitrari
 ly. It is required in order to \"close-the-loop\" on corrective and/or
  preventive actions (CAPA), and do proper impact analysis / actions. S
 uch failure investigation and root cause analysis is a major element o
 f cGMP compliance. If inadequately performed it is also a key source o
 f regulatory problems. How can companies allocate scarce resources to 
 those activities that have the greatest impact to product quality / sa
 fety, minimize resources on minor issues, and still satisfy the regula
 tory agencies? How can line operators' brains be engaged by the use of
  such simple yet powerful tools? Use the templates, tools and methodol
 ogy presented in this webinar to facilitate a closed-loop problem reso
 lution system to reduce \"fire fighting\" and minimize compliance prob
 lems.\nWhy you should attend:\nExpectations for meaningful CAPA, suppo
 rted by results-driven Failure Investigation and Root Cause Analysis, 
 that addresses and resolves underlying product problems, are growing a
 mong regulatory agencies world-wide. EU's ISO 14971 (Device Risk Manag
 ement) and the FDA's QSIT (devices) and ICH Q9 (drugs), underscore thi
 s increased emphasis. A valid closed-loop CAPA system requires defined
  failure investigation including systemic root cause analysis for true
  problem (not symptom) resolution. Growing high-profile field problems
  indicate that such effective and repeatable failure investigation and
  root cause analysis is still not the industry norm.\nAreas Covered in
  the Session:\nRegulatory \"Hot Buttons\" The 4 Basic Steps to Problem
  SolvingA Suggested Investigation TemplateID / Document the Problem - 
 CAPA, et alFailure Investigation / Analysis Methodology - And One Poss
 ible TemplateUse the 7 Tools to Find the Solution(s)Monitor for Effect
 ivenessLock In the Change - Close the Loop Take It to the Next Level\n
 Who Will Benefit:\nSenior management in Drugs, Devices, Biologics, Die
 tary Supplements QARAR&DEngineeringProductionOperationsConsultants; ot
 hers tasked with product, process, CAPA resolution, failure investigat
 ion responsibilities\nSpeaker Profile:\nJohn E. Lincoln is a medical d
 evice and regulatory affairs consultant. He has helped companies to im
 plement or modify their GMP systems and procedures, product risk manag
 ement, U.S. FDA responses. In addition, he has successfully designed, 
 written and run all types of process, equipment and software qualifica
 tions/validations, which have passed FDA audit or submission scrutiny,
  and described in peer-reviewed technical articles, and workshops, wor
 ld wide. John has also managed pilot production, regulatory affairs, p
 roduct development/design control, 510(k) submissions, risk management
  per ISO 14971, and projects; with over 28 years of experience in the 
 FDA-regulated medical products industry - working with start-ups to Fo
 rtune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mall
 inckrodt. He is a graduate of UCLA.\nContact Detail:\nNetZealous - Com
 pliance4All,161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA.P
 hone: +1-800-447-9407Email: support@compliance4All.comhttp://www.compl
 iance4all.com/Event Link : http://bit.ly/1RAweuA\n\nFor more informat
 ion visit https://medtechiq.ning.com/events/webinar-on-capa-failure-in
 vestigation-and-root-cause-analysis-to
DTSTART;TZID=America/New_York:20151202T100000
DTEND;TZID=America/New_York:20151202T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:
URL:
CONTACT:8004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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