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DTSTART:19700308T020000
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UID:2140535:Event:56682
DTSTAMP:20260518T042232Z
SUMMARY:Verification and Validation – Product, Equipment, Software a
 nd QMS
DESCRIPTION:Course Description:\nDevelop / review a company's Master V
 alidation Plan for major cGMP deficiencies. Address the U.S. FDA's new
 er and tougher regulatory stance. One major failing is lack of suffici
 ent or targeted risk-based V&V planning:\n\nStart with a Master Valida
 tion Plan;\nEvaluate its elements against ISO 14971 and ICH Q9 for haz
 ard analysis and product 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 “draw
 ing a line in the sand”;\n\nCourse Objectives:\n\nUnderstand Verific
 ation and Validation, differences and how they work together;\nDiscuss
  recent regulatory expectations;\nHow to document a “risk-based” r
 ationale, and use it in a resource-constrained environment;\nDetermine
  key “milestones” and “tasks” in a project;\nLocate and docume
 nt key subject “inputs”;\nCompile “generic” Master and Individ
 ual Validation Plans;\nLean the key element of a Product V&V File / Pr
 otocol;\nHow to develop Process and/or Production / Test Equipment V&V
  Files / Protocols;\nBasic Test Case construction;\nSample sizes and t
 heir justification;\nLean the key elements of Software V&V expected by
  the FDA and how to document;\nSee how to compile QMS Electronic Recor
 ds and Electronic Signatures V&Vs;\n\n\nFor more information visit htt
 ps://medtechiq.ning.com/events/verification-and-validation-product-equ
 ipment-software-and-qms
DTSTART;TZID=America/New_York:20120927T083000
DTEND;TZID=America/New_York:20120928T163000
CATEGORIES:medical, device, training
LOCATION:Grand Hyatt San Francisco
WEBSITE:http://www.complianceonline.com/ecommerce/control/seminar?prod
 uct_id=80058SEM&?channel=MedtechIQ
URL:http://www.complianceonline.com/ecommerce/control/seminar?product_
 id=80058SEM&?channel=MedtechIQ
CONTACT:+1-650-620-3915
ORGANIZER;CN=Referral:https://medtechiq.ning.com/profile/Referral
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Referral:
 https://medtechiq.ning.com/profile/Referral
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