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DTSTAMP:20260520T113155Z
SUMMARY:Drafting a Software V&V Documentation Package and Protocol
DESCRIPTION:Overview: The verification and validation of medical softw
 are is coming under increased scrutiny by the U.S. FDA. This webinar 
 will address the use of the FDA, DAMP, and other applicable industry s
 oftware validation models, coupled with the ISO 14971 / ICH Q9 Risk Ma
 nagement models, to structure, run, and document acceptable software v
 alidations. The FDA and other regulatory agencies have stated that sof
 tware validation can only be accomplished effectively if \"risk-based\
 ".  How can this be realistly accomplished. This webinar will addres
 s software that is:\nAs-Product;\nIn-Product;\nIn Production and Test 
 Equipment; and\nThe Quality System.\n\nA manufacturer is responsible t
 o identify these requirements and implement them into an effective sof
 tware V&V process. Areas Covered in the Session:\n\nVerification or V
 alidation\nCurrent  Regulatory Expectations  and “Hot Buttons”\n
 The Project Validation Plan\nProduct and Process / Equipment Software 
 V&V\nWhen and How to Use DQ, IQ, OQ, PQ\nGAMP Considerations\nThe FDA'
 s 11 Key Elements\n\"White Box\" and \"Black Box\" Validations\n\nWho 
 Will Benefit:\n\nSenior management, Project Leaders, Internal / Extern
 al consultants\nMid-level Management and Supervisory Personnel\nRegula
 tory Affairs\nQuality Systems Personnel / QAE\nR&D and Engineering Sta
 ff\nNew Product Development Personnel\nValidation Technicians\nIT Depa
 rtment\nMedical Device, Equipment / Process SW Programmers\n\n\n\n\nJo
 hn E. Lincoln is a medical device and regulatory affairs consultant. 
 He has helped companies to implement or modify their GMP systems and p
 rocedures, product risk management, U.S. FDA responses. In addition, h
 e has successfully designed, written and run all types of process, equ
 ipment and software qualifications/validations, which have passed FDA 
 audit or submission scrutiny, and described in peer-reviewed technical
  articles, and workshops, world wide. \n\nQuick Contact:\nGlobalCompl
 iancePanel USA Phone:800-447-9407webinars@globalcompliancepanel.comhtt
 p://www.globalcompliancepanel.comEvent Link - http://bit.ly/MQdBrI\n\
 n\n\n\n\nFor more information visit https://medtechiq.ning.com/events/
 drafting-a-software-v-v-documentation-package-and-protocol
DTSTART;TZID=America/New_York:20140318T100000
DTEND;TZID=America/New_York:20140318T110000
CATEGORIES:webinar, pharma, medical, clinical, health
LOCATION:Online Event
WEBSITE:http://bit.ly/MQdBrI
URL:http://bit.ly/MQdBrI
CONTACT:8004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562011438?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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