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DTSTAMP:20260526T105156Z
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).\nThis course benefits anyone that u
 ses computer systems to perform their job functions and is ideal for p
 rofessionals working in the health care, clinical trial, biopharmaceut
 ical, and medical device sectors. It is essential for software vendors
 , auditors, and quality staff involved in GxP applications.\n\n\nLearn
 ing Objectives:\n\nReduce costs, usually by two-thirds, for compliance
  with electronic records\nLearn how to use electronic records and elec
 tronic signatures to maximize productivity\nUnderstand what is expecte
 d in Part 11 and Annex 11 inspections so you are prepared\nAvoid 483 a
 nd Warning Letters\nUnderstand the responsibilities and specific dutie
 s of your staff including IT 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\nHow to 
 select resources and manage validation projects\n\"Right size\" change
  control methods that allows quick and safe system evolution\nMinimize
  validation documentation to reduce costs without increasing regulator
 y or business risk\nLearn how to reduce testing time and write test ca
 ses that trace to elements of risk management\nLearn how to comply wit
 h the requirements for data privacy\nLearn how to buy COTS software an
 d qualify vendors\nProtect intellectual property and keep electronic r
 ecords safe\n\nWho will Benefit:\n\nGMP, GCP, GLP, regulatory professi
 onals\nQA/QC\nIT\nAuditors\nManagers and directors\nSoftware vendors, 
 SaaS hosting providers\n\n\nFor more information visit https://medtech
 iq.ning.com/events/21-cfr-part-11-compliance-for-saas-cloud-applicatio
 ns
DTSTART;TZID=America/New_York:20210127T090000
DTEND;TZID=America/New_York:20210128T150000
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;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
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ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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