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DTSTART:19700308T020000
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UID:2140535:Event:66526
DTSTAMP:20260911T212631Z
SUMMARY:Webinar On IQ, OQ, PQ in the Verification and Validation Proce
 ss
DESCRIPTION:Description :\nThis webinar will discuss the Consideration
  of IQ, OQ, and PQ and their equivalents for processes, equipment (pro
 duction and test), product, and CGMP e-records / e-signatures.\nFDA Wa
 rning Letters and recent high-profile recalls indicate major cGMP defi
 ciencies in big name device and pharma companies, many going back to i
 nsufficient, poor or non-existent product / equipment / process V&V re
 quirements and execution. And now the FDA is taking an even tougher st
 ance.\nWhy do companies need robust V&V?\nWhat are the \"must have\" e
 lements from  the CGMPs and best practices?\nHow do you define and us
 e IQ, OQ, PQ, or their equivalents?\nHow do ISO 14971 and ICH Q9 for h
 azard analysis and product risk management factor in and assist to all
 ocating limited company resources?\nHow can these be integrated into t
 he company's quality management system?\nWhile focused on CGMP complia
 nce, it is suitable for ISO 13485 and ISO 9001 (international / global
 ) compliance as well.\nAreas Covered in the Session :\nIQ, OQ, and PQ,
  major components of robust Verification and Validation V&V programs -
  Regulatory requirements\nThe Master Validation Plan(s)\nIndividual V&
 V Plans and their execution\nProduct Verification and Validation\nProc
 ess and Equipment V&V; including software\nQMS V&V and 21 CFR Part 11\
 nWhen / How to Use DQ, IQ, OQ, PQ, or ASTM E2500 Equivalents\nThe 11 E
 lements of the FDA's Software VT&V \"Model\"\nIncorporating the Hazard
  Analysis / Risk Management tools of ISO 14971 or ICH Q9\nHow to Avoid
  recent compliance problems\nWho Will Benefit:\nThis webinar will prov
 ide valuable assistance to all regulated companies that need to review
  and modify their company's planning and execution of verification and
  validation, based on a proper understanding of the roles of IQ, OQ, a
 nd PQ, or equivalent terminology. Its principles apply to personnel / 
 companies in the Medical Devices, Pharmaceutical, Diagnostic, and Biol
 ogics fields. The employees who will benefit include:\nSenior manageme
 nt\nMiddle management\nResearch & Development\nEngineering\nSoftware\n
 QA / RA\nManufacturing\nOperators\nConsultants\ncGMP instructors\nAll 
 personnel involved in verification and/or validation planning, executi
 on and documentation.\n\nFor more information visit https://medtechiq.
 ning.com/events/webinar-on-iq-oq-pq-in-the-verification-and-validation
 -process
DTSTART;TZID=America/New_York:20150818T130000
DTEND;TZID=America/New_York:20150818T140000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1544
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1544
CONTACT:4169154458
ORGANIZER:Compliance Trainings
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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