BEGIN:VCALENDAR
PRODID:-//github.com/rianjs/ical.net//NONSGML ical.net 4.0//EN
VERSION:2.0
BEGIN:VEVENT
DESCRIPTION:This webinar addresses the Computer Software Assurance guidanc
 e related to 21 CFR Part 11\, and the European equivalent Annex 11 for lo
 cal\, and SaaS/Cloud hosted applications. It details the evolution of ind
 ustry practices that increase productivity and ensure compliance. Learn t
 he latest validation models and fill-in-the-blank templates.\n\nLearning 
 Objectives:\n\n\nWhich data and systems are subject to&nbsp\;Part 11 and 
 Annex 11\nComputer Software Assurance impact on risk-based\nImpact of Ele
 ctronic Systems… Clinical Investigations Q&amp\;A Guidance for Industry O
 ct 2024\nAvoid 483 and Warning Letters\nRequirements for local\, SaaS\, a
 nd cloud hosting\nReduce validation resources by using easy to understand
  fill-in-the-blank validation documents\n\nAreas Covered in the Webinar:\
 n\n\nWhat 21 CFR Part 11 means today\n\nPurpose of Part 11\n\n\nWhat does
  Part 11 mean?\n\nSOPs\nSystem features\nInfrastructure qualification\nVa
 lidation\n\n\nHardware is qualified\n\nIQ/OQ/PQ\n\n\nGAMP categories\n\nN
 o validation\nSoftware Validation (SV)\nComputer System Validation (CSV)\
 n\n\nExpansion for industry categories\n\nQualification of software utili
 ties\nHybrid Validation\nStatistical Analysis Program Validation\nMedical
  Device Software Validation\n\n\nEvolution of COTS CSV\n\nTest-based\nRis
 k-based\n\n\nValidation\n\nSoftware Validation for vendors\nComputer Syst
 em Validation for users\nChange control re-validation\n\n\nSaaS/Cloud hos
 ting\n\nResponsibilities for software vendor and hosting provider\nEvalua
 tion criteria\nHosting requirements\n\n\nHow to implement compliance\n\nS
 oftware inventory\nValidation models and templates\n\n\n\nWho Will Benefi
 t:\n\n\nGMP\, GCP\, GLP\, regulatory professionals\nQA/QC\nIT\nAuditors\n
 Managers and directors\nSoftware vendors\, hosting providers\n\nIndustrie
 s which will get benefit from this training include Pharmaceutical\, Medi
 cal Device\, Biologics\, Food\, Cosmetics\, FDA regulated companies\, Sof
 tware vendors\, SaaS providers\, Data centers\n
DTEND:20250324T111500
DTSTAMP:20260512T232941Z
DTSTART:20250324T100000
LOCATION:\,
SEQUENCE:0
SUMMARY:This webinar addresses the Computer Software Assurance guidance re
 lated to 21 CFR Part 11\, and the European equivalent Annex 11 for local\
 , and SaaS...
UID:d5100efb-5740-4cf3-a1e2-45aa47b729a0
END:VEVENT
END:VCALENDAR