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DTSTART:19700308T020000
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UID:2140535:Event:471890
DTSTAMP:20260524T150635Z
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.\nParticipants will lear
 n how to write a Data Privacy Statement to comply with the EU General 
 Data Protection Regulation (GDPR).\n\nLearning Objectives:\n\nReduce c
 osts, usually by two-thirds, for compliance with electronic records\nL
 earn how to use electronic records and electronic signatures to maximi
 ze productivity\nUnderstand what is expected in Part 11 and Annex 11 i
 nspections so you are prepared\nAvoid 483 and Warning Letters\nUnderst
 and the responsibilities and specific duties of your staff including I
 T and QA\nUnderstand your responsibilities and liabilities when using 
 SaaS/cloud\nLearn how to perform risk-based Computer System Validation
  using fill-in-the-blank templates\n\nWho will Benefit:\n\nGMP, GCP, G
 LP, regulatory professionals\nQA/QC\nIT\nAuditors\nManagers and direct
 ors\nSoftware vendors, SaaS hosting providers\n\n\nFor more informatio
 n visit https://medtechiq.ning.com/events/21-cfr-part-11-compliance-fo
 r-saas-cloud-applications-5
DTSTART;TZID=America/New_York:20220516T090000
DTEND;TZID=America/New_York:20220517T150000
CATEGORIES:seminae
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/10383283896?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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