BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:470770 DTSTAMP:20260531T120338Z SUMMARY:Validation Master Plan - The Unwritten Requirements DESCRIPTION:This 60-minute session on master verification and validati on planning will discuss the major cGMP deficiencies and \"must have\" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard anal ysis and product risk management, and show how you can integrate these into a company's quality management system.\nWhy Should You Attend:\n FDA Warning Letters and recent high-profile recalls indicate major cGM P deficiencies in big name device and pharma companies. One major fail ing is lack of sufficient or targeted risk-based V&V planning. But a r eview of Internet forums shows confusion as to what is V&V planning.\n \nWhat really is a Master Validation Plan?\nWhy do companies need one? \nWhat is the individual V&V plan and its high value.\nWhat are the \" must have\" elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management?\nHow can these be integrated?\nSoftware / fi rmware V&V?\n\nReview a company's Validation Master Plan for major cGM P deficiencies. Address the FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V pl anning. Starting with a Validation Master Plan, evaluating its element s against ISO 14971 and ICH Q9 for hazard analysis and product risk ma nagement, allows the development of meaningful product and process val idations. Also the role of the individual V&V plan, and different prot ocols; how to employ equipment / process DQs, IQs, OQs, and PQs, or th eir equivalents, against a background of limited company resources. Ou r matrix simplifies \"as-product\", in-product\", process and equipmen t, et al, software VT&V, assuring key FDA requirements are not overloo ked. The QMS and 21 CFR Part 11 are considered.\n\nAreas Covered in the Webinar:\n\nVerification or Validation - Recent regulatory expecta tions\nThe Master Validation Plan\nThe Individual V&V Plan\nProduct V& V versus Process / Equipment V&V\nWhen / How to Use DQ, IQ, OQ, PQ, AS TM E2500 Equivalents\nUsing the Risk Management tools of ISO 14971 and ICH Q9\nThe 11 Elements of the Software VT&V \"Model\"\nKey recent co mpliance problems\n\nWho Will Benefit:\nThis webinar will provide valu able assistance to all regulated companies that need to review and mod ify their Master Validation Planning and Plan(s). While this informati on is focused on Medical Devices, its principles apply to personnel / companies in the Pharmaceutical, Diagnostic, and Biologics fields. The employees who will benefit include:\n\nSenior management\nRegulatory Affairs\nQuality Assurance\nProduction\nEngineering, including Softwar e\n\n\nFor more information visit https://medtechiq.ning.com/events/va lidation-master-plan-the-unwritten-requirements DTSTART;TZID=America/New_York:20211207T100000 DTEND;TZID=America/New_York:20211207T130000 CATEGORIES:webinar LOCATION:online WEBSITE:https://www.complianceonline.com/validation-master-plan-the-un written-requirements-webinar-training-705877-prdw?channel=MedTech%20I. Q URL:https://www.complianceonline.com/validation-master-plan-the-unwrit ten-requirements-webinar-training-705877-prdw?channel=MedTech%20I.Q CONTACT:8887172436 ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer ral512 ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0 /file/get/9855359876?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc eOnline:https://medtechiq.ning.com/profile/Referral512 END:VEVENT END:VCALENDAR