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DTSTAMP:20260413T011052Z
SUMMARY:Webinar on Drafting a Software V&V Documentation Package and P
 rotocol
DESCRIPTION:Overview: The verification and validation of medical soft
 ware is coming under increased scrutiny by the U.S. FDA.\nThis webinar
  will address the use of the FDA, DAMP, and other applicable industry 
 software validation models, coupled with the ISO 14971 / ICH Q9 Risk M
 anagement models, to structure, run, and document acceptable software 
 validations. The FDA and other regulatory agencies have stated that so
 ftware validation can only be accomplished effectively if \"risk-based
 \".  How can this be realistly accomplished. This webinar will addre
 ss software that is:\n\nAs-Product;\nIn-Product;\nIn Production and Te
 st Equipment; and\nThe Quality System.\n\nA manufacturer is responsibl
 e to identify these requirements and implement them into an effective 
 software V&V process.\n \nAreas Covered in the Session:\nVerification
  or Validation\nCurrent  Regulatory Expectations  and “Hot Buttons
 ”\nThe Project Validation Plan\nProduct and Process / Equipment Soft
 ware 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 / E
 xternal consultants\nMid-level Management and Supervisory Personnel\nR
 egulatory Affairs\nQuality Systems Personnel / QAE\nR&D and Engineerin
 g Staff\nNew Product Development Personnel\nValidation Technicians\nIT
  Department\nMedical Device, Equipment / Process SW Programmers\n\nSpe
 aker Profile: \n\nJohn E Lincoln is a medical device and regulatory
  affairs consultant. He has helped companies to implement or modify th
 eir GMP systems and procedures, product risk management, U.S. FDA resp
 onses. In addition, he has successfully designed, written and run all 
 types of process, equipment and software qualifications/validations, w
 hich have passed FDA audit or submission scrutiny, and described in pe
 er-reviewed technical articles, and workshops, world wide. John has al
 so managed pilot production, regulatory affairs, product development/d
 esign control, 510(k) submissions, risk management per ISO 14971, and 
 projects; with over 28 years of experience in the FDA-regulated medica
 l products industry - working with start-ups to Fortune 100 companies,
  including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a gr
 aduate of UCLA.\n\n\nContact Detail:\nCompliance4All DBA NetZealous,Ph
 one: +1-800-447-9407Email: support@compliance4All.comhttp://www.compli
 ance4all.com/Event Link : http://bit.ly/Drafting_a_Software\nLinkedIn
  Follow usTwitter Follow usFacebook Like us\n\n\nFor more information 
 visit https://medtechiq.ning.com/events/webinar-on-drafting-a-software
 -v-v-documentation-package-and
DTSTART;TZID=America/New_York:20160525T100000
DTEND;TZID=America/New_York:20160525T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://bit.ly/Drafting_a_Software
URL:http://bit.ly/Drafting_a_Software
CONTACT:18004479407
ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia
 nce4all
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562012364?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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