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DTSTART:19700308T020000
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UID:2140535:Event:64117
DTSTAMP:20260520T110341Z
SUMMARY:Webinar On Robust Corrective And Preventive Action (CAPA)
DESCRIPTION:Vital elements of a robust, \"bullet-proof\", \"closed-loo
 p\"  Corrective and Preventive Action (CAPA) program include: \"Gatek
 eeper\" capture, investigation, verify/validate, monitor, change contr
 ol methodology, coupled with accurate root cause analysis. Such a \"cl
 osed-loop\" CAPA system will meet / exceed CGMP requirements and U.S. 
 FDA expectations. Robust CAPA requires a specific sequence of activiti
 es, each building on the other, to enhance patient safety and improve 
 product quality.\nIt is also key to many other important cGMP activiti
 es -- Non-conformance / OOS resolution, Complaint Handling, Adverse Ev
 ent Reporting and Resolution, other Verification and Validation activi
 ties, Audit corrective and preventive actions, et al. Simple tools and
  work flow are not understood, diseminated, and used, consistently.  
 Product failures, liability issues, scrap / waste / fall off, and need
 less recalls result, as evidenced in recent notorious events.\nAvoid a
  \"shoot from the hip\" approach.  Define, then attack, and resolve r
 oot problems / causes, not just symptoms, using repeatable, systematic
 , SOP-defined methods as part of the \"closed-loop\" CAPA system.\nA r
 obust CAPA requires repeatable, systematic Failure Investigation and R
 oot Cause Analysis. The FDA has faulted companies repeatedly for failu
 re to identify, systematically investigate, resolve, and then verify/v
 alidate and monitor for reslution of the key underlying problem -- bas
 ically an inability to define, locate and resolve the basic problem(s)
  or root cause(s) -- using a repeatable system.\nThe most important ar
 ea audited by the FDA is CAPA -- it assures the FDA that company is in
  compliance without the Agency constantly auditing it. One of the most
  cited 483 observation is failure to resolve the key underlying proble
 m and close out CAPA documents in a timely manner -- basically an inab
 ility to define, locate and resolve the basic problem(s) or root cause
 (s). Regular, defined, systematic use of a few simple but powerful too
 ls can contribute greatly to reduction of product liability, cost redu
 ction efforts, less chance of recalls, and an improved bottom line.\nA
 reas Covered in the Session :\nRegulatory \"Hot Buttons\"\nCAPA Backgr
 ound\nCorrection, Corrective Action, Preventive Action Defined\nImpact
  Analysis and Response - a Key Component\nCAPA System Assessment\n\"Bu
 llet-Proof\"\nData Sources / Metrics\nMonitor for Effectiveness\n\"Clo
 sed-Loop\" - Lock In the Change\nBeyond Regulatory Compliance\nWho Wil
 l Benefit:\nThis 90 minute in-depth webinar will provide valuable assi
 stance to all regulated companies that need to review and modify their
  company's CAPA system.\nIts principles apply to personnel / companies
  in the Medical Devices, Pharmaceutical, Diagnostic, and Biologics fie
 lds. The employees who will benefit include:\nSenior management\nMiddl
 e management\nR&D\nEngineering\nSoftware\nQA / RA\nManufacturing\nOper
 ators\nConsultants\ncGMP instructors\nAnd all personnel involved in ve
 rification and/or validation planning, execution and documentation.\nP
 rice Tags:\nLive\nSingle Live : For One Participant\n$ 249\nCorporate 
 Live : For Max. 10 Participants\n$ 899\nRecording\nSingle REC : For On
 e Participant - Unlimited Access for 6 Months\n$ 299\n\nFor more infor
 mation visit https://medtechiq.ning.com/events/webinar-on-robust-corre
 ctive-and-preventive-action-capa
DTSTART;TZID=America/New_York:20140813T140000
DTEND;TZID=America/New_York:20140813T143000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1264
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1264
CONTACT:4169154458
ORGANIZER;CN=compliancetrainings:https://medtechiq.ning.com/profile/co
 mpliancetrainings
ATTACH;FMTTYPE="image/jpeg":
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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