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UID:2140535:Event:66939
DTSTAMP:20260524T122018Z
SUMMARY:Webinar on Software Verification and Validation Planning and D
 ocumentation
DESCRIPTION:Overview: The verification and validation of medical soft
 ware is coming under increased scrutiny by the U.S. FDA. This webinar 
 will address the use of the FDA, GAMP, 21 CFR Part 11, \"Electronic Re
 cords\" / \"Electronic Signatures\", and other applicable industry sof
 tware validation models, coupled with the ISO 14971 / ICH Q9 Product R
 isk Management models, to plan, structure, run, and document acceptabl
 e software validations.\n\nWhy should you attend: \nSoftware has beco
 me pervasive in medical devices themselves, and in the controlling, ru
 nning and monitoring of medical product processes, whether they be in 
 the pharmaceutical, medical device, biologics or dietary supplements i
 ndustries. A quick review of Internet forums will show much confusion 
 about the subject. Software is being developed for medical imaging, an
 d even thought control of computers. It is increasingly being used for
  e-records and e-signatures. Areas Covered in the Session:\nVerificat
 ion or Validation - FDA Expectations\nThe Project Validation Plan\nAn 
 FDA-accepted Documentation \"Model\"\nProduct and Process / Test / Fac
 ilities / Equipment Software V&V\nWhen and How to Use DQ, IQ, OQ, PQ (
 or their equivalents)\nGAMP / Other Considerations\nThe FDA's 11 Key V
 &V Documentation Elements\n\"White Box\" and \"Black Box\" Validations
 \n\nWho Will Benefit:\n\nSenior management in Drugs, Devices, Combinat
 ion Products, Biologics, Dietary Supplements\nQA / RA\nSoftware develo
 pment, programming, documentation, testing teams\nR&D\nEngineering\nPr
 oduction\nOperations\nConsultants\n\n\n\nSpeaker Profile:John E. Linco
 ln is a medical device and regulatory affairs consultant. He has help
 ed companies to implement or modify their GMP systems and procedures, 
 product risk management, U.S. FDA responses. In addition, he has succe
 ssfully designed, written and run all types of process, equipment and 
 software qualifications/validations, which have passed FDA audit or su
 bmission scrutiny, and described in peer-reviewed technical articles, 
 and workshops, world wide. John has also managed pilot production, reg
 ulatory affairs, product development/design control, 510(k) submission
 s, risk management per ISO 14971, and projects; with over 28 years of 
 experience in the FDA-regulated medical products industry - working wi
 th start-ups to Fortune 100 companies, including Abbott Laboratories, 
 Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.\nContact Detail:
 \nNetZealous - Compliance4All,161 Mission Falls Lane, Suite 216, Fremo
 nt, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4Al
 l.comhttp://www.compliance4all.com/Event Link : http://bit.ly/1KNlp7R
 \n\n\n\nFor more information visit https://medtechiq.ning.com/events/w
 ebinar-on-software-verification-and-validation-planning-and
DTSTART;TZID=America/New_York:20151110T100000
DTEND;TZID=America/New_York:20151110T113000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://bit.ly/1KNlp7R
URL:http://bit.ly/1KNlp7R
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/2562012284?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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