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DTSTART:19700308T020000
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UID:2140535:Event:79085
DTSTAMP:20260523T225938Z
SUMMARY:Verification vs Validation-Product, Equipment and QMS Software
DESCRIPTION:Overview:You will learn What do the U.S. FDA and EU Expect
  for Verification and Validation, Actions and documentation to meet U.
 S. FDA CGMP, ICH Q-series, and ISO 13485 expectations and requirements
 , ISO 14971 and IEC 62366 considerations, as appropriate.\nWhy should 
 you Attend:The FDA / ICH Q-series provide valuable insights for all re
 gulated industries, not just pharma. Why \"working definitions\"? What
 's a field proven approach. Requirements to qualifications to test cas
 es to the validation.\nAreas Covered in the Session:Verification or Va
 lidation Recent regulatory expectationsThe Validation Master Plan and 
 its structureProduct Validation - how it differs from process / equipm
 ent V&VProcess / Equipment / Facility Validation includingFDA's recent
  guidance\nWho Will Benefit:Senior management in Drugs, Devices, Biolo
 gics, DietarySupplementsQARAR&DEngineeringProductionOperations\nSpeake
 r Profile: John E. Lincoln is a medical device and regulatory affairs 
 consultant. He has helped companies to implement or modify their GMP s
 ystems and procedures, product risk management, U.S. FDA responses. In
  addition, he has successfully designed, written and run all types of 
 process, equipment and software qualifications/validations, which have
  passed FDA audit or submission scrutiny, and described in peer-review
 ed technical articles, and workshops, world wide.\nEvent Fee: One Dial
 -in One Attendee Price: US $290.00\nContact Detail:Compliance4All DBA 
 NetZealous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\n
 For more information visit https://medtechiq.ning.com/events/verificat
 ion-vs-validation-product-equipment-and-qms-software
DTSTART;TZID=America/New_York:20180815T080000
DTEND;TZID=America/New_York:20180815T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 2001LIVE?channel=medtechiq_Aug_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=502001
 LIVE?channel=medtechiq_Aug_2018_SEO
CONTACT:8004479407
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/2562016576?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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