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DTSTART:19700308T020000
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UID:2140535:Event:470612
DTSTAMP:20260602T103757Z
SUMMARY:21 CFR Part 11 Compliance for SaaS/Cloud Applications
DESCRIPTION:This highly interactive two-day course uses real life exam
 ples and explores proven techniques for reducing costs, usually by two
 -thirds, associated with implementing, and maintaining computer system
 s in regulated environments.\n\nIt details the requirements for Part 1
 1 and Annex 11: SOPs, software product features, infrastructure qualif
 ication, and validation.\nThe instructor addresses the latest computer
  system industry standards for data security, data transfer, audit tra
 ils, electronic records and signatures, software validation, and compu
 ter system validation.\nUnderstand the specific requirements associate
 d with local and SaaS/cloud hosting solutions.\nNearly every computeri
 zed system used in laboratory, clinical, manufacturing settings and in
  the quality process has to be validated. Participants learn how to de
 crease software implementation times and lower costs using a 10-step r
 isk-based approach to computer system validation.\nThe instructor revi
 ews recent FDA inspection trends and discusses how to streamline docum
 ent authoring, revision, review, and approval.\n\nLearning Objectives:
 \n\nReduce costs, usually by two-thirds, for compliance with electroni
 c records\nLearn how to use electronic records and electronic signatur
 es to maximize productivity\nUnderstand what is expected in Part 11 an
 d Annex 11 inspections so you are prepared\nAvoid 483 and Warning Lett
 ers\nUnderstand the responsibilities and specific duties of your staff
  including IT and QA\nUnderstand your responsibilities and liabilities
  when using SaaS/cloud\n\nWho will Benefit:\n\nGMP, GCP, GLP, regulato
 ry professionals\nQA/QC\nIT\nAuditors\nManagers and directors\nSoftwar
 e vendors, SaaS hosting providers\n\n\nFor more information visit http
 s://medtechiq.ning.com/events/21-cfr-part-11-compliance-for-saas-cloud
 -applications-2
DTSTART;TZID=America/New_York:20211208T090000
DTEND;TZID=America/New_York:20211209T150000
CATEGORIES:webinar
LOCATION:online
WEBSITE:https://www.complianceonline.com/21-cfr-part-11-compliance-for
 -saas-cloud-applications-seminar-training-80202SEM-prdsm?channel=MedTe
 ch%20I.Q
URL:https://www.complianceonline.com/21-cfr-part-11-compliance-for-saa
 s-cloud-applications-seminar-training-80202SEM-prdsm?channel=MedTech%2
 0I.Q
CONTACT:8887172436
ORGANIZER:Complianceonline
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/9754830492?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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