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UID:2140535:Event:65195
DTSTAMP:20260522T121750Z
SUMMARY:Webinar On Robust Verification and Validation
DESCRIPTION:Description :\nThis 90 minute in-depth webinar discusses t
 he FDA Warning Letters and recent high-profile recalls indicate major 
 cGMP deficiencies in big name device and pharma companies, many going 
 back to insufficient, poor or non-existent V&V planning.\nAnd now the 
 FDA is taking an even tougher stance.\nWhy do companies need robust V&
 V?\nWhat are the \"must have\" elements from  the cGMPs?\nHow do ISO 
 14971 and ICH Q9 for hazard analysis and product risk management facto
 r in and assist to allocating limited company resources?\nHow can thes
 e be integrated into the company's quality management system?\nAreas C
 overed in the Session :\nRobust Verification and Validation -- Recent 
 Regulatory requirements.\nThe Master Validation Plan(s).\nIndividual V
 erification and Validation Plans and their execution.\nProduct Verfica
 tion & Validation.\nProcess and Equipment Verfication & Validation, in
 cluding Software.\nQMS V&V and 21 CFR Part 11.\nWhen and How to Use DQ
 , IQ, OQ, PQ, or ASTM E2500 Equivalents.\nThe 11 Elements of the FDA's
  Software V&V \"Model\".\nIncorporate the Hazard Analysis / Risk Manag
 ement tools of ISO 14971 and ICH Q9.\nAvoid recent compliance problems
 .\nWho Will Benefit:\nThis webinar will provide valuable assistance to
  all regulated companies that need to review and modify their company'
 s planning and execution of verification and validation. Its principle
 s apply to personnel / companies in the Medical Devices, Pharmaceutica
 l, Diagnostic, and Biologics fields. The professionals who will benefi
 t include all:\nSenior management\nMiddle management\nR&D\nEngineering
 \nSoftware\nQA / RA\nManufacturing\nOperators\nConsultants\ncGMP instr
 uctors\nAnd all personnel involved in verification and/or validation p
 lanning, execution and documentation.\nPrice Tags:\nLive\nSingle Live 
 : For One Participant\n$ 249\nCorporate Live : For Max. 10 Participant
 s\n$ 899\nRecording\nSingle REC : For One Participant - Unlimited Acce
 ss for 6 Months\n$ 299\nFor more information and enquiries contact us 
 at\nCompliance Trainings\n5939 Candlebrook Ct, Mississauga, ON L5V 2V
 5, Canada Customer Support : 4169154458  Email : support@compliance
 trainings.com\nFor more information about this event please visit\nhtt
 ps://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD12
 68\nLike Us On facebook:\nhttps://www.facebook.com/events/152018329157
 9565/?source=1&sid_create=80105171\n\nFor more information visit https
 ://medtechiq.ning.com/events/webinar-on-robust-verification-and-valida
 tion
DTSTART;TZID=America/New_York:20150210T130000
DTEND;TZID=America/New_York:20150210T143000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:https://compliancetrainings.com/SiteEngine/ProductDetailView.a
 spx?id=MD1268
URL:https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?
 id=MD1268
CONTACT:4169154458
ORGANIZER:Compliance Trainings
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011796?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=complianc
 etrainings:https://medtechiq.ning.com/profile/compliancetrainings
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