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DTSTAMP:20260530T121838Z
SUMMARY:Which data and systems are subject to Part 11
DESCRIPTION:Overview: This webinar details the regulation and how it a
 pplies to computerized systems. Learn exactly what is needed to be com
 pliant for all three primary areas: SOPs for the IT infrastructure, in
 dustry standards for software product features, and the 10-step risk-b
 ased validation approach.\nAreas Covered in the Session:Which data and
  systems are subject to Part 11What Part 11 means to you, not just wha
 t it says in the regulationAvoid 483 and Warning LettersExplore the th
 ree primary areas of Part 11 compliance: SOPs, software product featur
 es, and validation documentationEnsure data integrity, security, and p
 rotect intellectual property\nWho Will Benefit:ITQAQCLaboratory StaffM
 anagersGMP, GCP, GLP Professionals\nSpeaker Profile:Edwin Waldbusser i
 s a consultant retired from industry after 20 years in management of d
 evelopment of medical devices (5 patents). He has been consulting in t
 he US and internationally in the areas of design control, risk analysi
 s and software validation for the past 8 years.\nEvent Fee: One Dial-i
 n One Attendee Price: US$150.00\nContact Detail:Compliance4All DBA Net
 Zealous,Phone: +1-800-447-9407Email: support@compliance4All.com\n\nFor
  more information visit https://medtechiq.ning.com/events/which-data-a
 nd-systems-are-subject-to-part-11
DTSTART;TZID=America/New_York:20180116T100000
DTEND;TZID=America/New_York:20180116T113000
CATEGORIES:online
LOCATION:Fremont
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1619LIVE?channel=medtechiq_Jan_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501619
 LIVE?channel=medtechiq_Jan_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562015774?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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