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DTSTART:19700308T020000
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UID:2140535:Event:470636
DTSTAMP:20260405T151629Z
SUMMARY:Verification and Validation - Product, Equipment/Process, Soft
 ware and QMS
DESCRIPTION:Develop / review a company's Master Validation Plan for ma
 jor cGMP deficiencies. Address the U.S. FDA's newer and tougher regula
 tory stance. One major failing is lack of sufficient or targeted risk-
 based V&V planning:\n\nStart with a Master Validation Plan;\nEvaluate 
 its elements against ISO 14971 and ICH Q9 for hazard analysis and prod
 uct risk management;\nThe Individual V&V Plan;\nV&V Project Management
 ;\n“Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;\nTwo key 
 input analysis tools;\nChange control and “drawing a line in the san
 d”;\nDevelop meaningful V&V Files and Protocols for:\nProducts;\nPro
 cess;\nProduction Equipment;\nMonitoring and Test Equipment;\nSoftware
 ;\nQuality Management System – 21 CFR 11, Electronic Records / Signa
 tures;\n\n\nThe roles of different V&V protocols;\n\nLearning Objectiv
 es:\n\nUnderstand Verification and Validation, differences and how the
 y work together\nDevelop a “Working Definition” of V&V, Qualificat
 ion, and related terms\nDiscuss recent regulatory expectations\nHow to
  document a “risk-based” rationale, and use it in a resource-const
 rained environment\nDetermine key “milestones” and “tasks” in 
 a project; device sample provided\nLocate and document key subject “
 inputs”\nCompile “generic” Master and Individual Validation Plan
 s\nLean the key element of a Product V&V File / Protocol\nHow to devel
 op Process and/or Production / Test Equipment V&V Files / Protocols\nB
 asic Test Case / Script construction\nSample sizes and their justifica
 tion\n\nWho will Benefit:\nThis seminar will provide valuable assistan
 ce to all regulated companies that need to review and modify their Mas
 ter Validation Planning and Plan(s). While this information is focused
  on Medical Devices, its principles apply to personnel / companies in 
 the Pharmaceutical, Diagnostic, and Biologics fields. The employees wh
 o will benefit include:\n\nSenior and middle management and staff\nReg
 ulatory Affairs\nQA/QC\nIT/IS\nR&D\nProduction Management\nManufacturi
 ng Engineers\nProcess Engineers\nSoftware Engineers\n\n\nFor more info
 rmation visit https://medtechiq.ning.com/events/verification-and-valid
 ation-product-equipment-process-software
DTSTART;TZID=America/New_York:20220118T090000
DTEND;TZID=America/New_York:20220119T160000
CATEGORIES:seminae
LOCATION:online
WEBSITE:https://www.complianceonline.com/verification-and-validation-p
 roduct-equipment-software-and-qms-seminar-training-80058SEM-prdsm?chan
 nel=MedTech%20I.Q
URL:https://www.complianceonline.com/verification-and-validation-produ
 ct-equipment-software-and-qms-seminar-training-80058SEM-prdsm?channel=
 MedTech%20I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9829214869?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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