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DESCRIPTION:This 21 CFR Part 11 compliance training will guide you through
  the requirements of Part 11 and will also explain its 3 primary areas: S
 OPs\, product features and validation (10 step risk based approach).\n\nW
 hy Should You Attend:\n\nThis webinar describes exactly what is required 
 for compliance with Computer Software Assurance guidance\, 21 CFR Part 11
 \, and the European equivalent Annex 11 for local\, and SaaS/Cloud hosted
  applications. It explains how to write a Data Privacy Statement for comp
 liance with EU General Data Protection Regulation (GDPR). What the regula
 tions mean is described for all four primary compliance areas: SOPs\, sof
 tware features\, infrastructure qualification\, and validation. It gets y
 ou on the right track for using electronic records and signatures to grea
 tly increase productivity and ensure compliance..\n\nAreas Covered in the
  Webinar:\n\n\nWhich data and systems are subject to Part 11 and Annex 11
 \nHow to write a Data Privacy Statement\nWhat the regulations mean\, not 
 just what they say\nAvoid 483 and Warning Letters\nRequirements for local
 \, SaaS\, and cloud hosting\nUnderstand the current industry standard sof
 tware features for security\, data transfer\, audit trails\, and electron
 ic signatures\nHow to use electronic signatures\, ensure data integrity\,
  and protect intellectual property\nSOPs required for the IT infrastructu
 re\nProduct features to look for when purchasing COTS software\nReduce va
 lidation resources by using easy to understand fill-in-the-blank validati
 on documents\n\nAgenda:\n\n\nWhat 21 CFR Part 11 means today\n\nPurpose o
 f Part 11\n\nWhat does Part 11 mean?\n\nSOPs\nSystem features\nInfrastruc
 ture qualification\nValidation\n\nSecurity standards\n\nRoles\nUsernames 
 and passwords\nRestrictions and logs\n\nData transfer standards\n\nDeleti
 ng data\nEncryption\n\nAudit trail standards\n\nTypes of data\nHigh risk 
 systems\n\nElectronic approval standards\n\nElectronic signatures\nSingle
  sign-on\nReplacing paper with electronic forms\n\nInfrastructure qualifi
 cation\n\nHow to efficiently document qualifications\n\nValidation\n\nSof
 tware validation for vendors\nComputer System Validation  for users\nFill
 -in-the-blank templates\nChange control re-validation\n\nSaaS/Cloud hosti
 ng\n\nResponsibilities for software vendor and hosting provider\nEvaluati
 on criteria\nHosting requirements\n\nSOPs\n\nIT\, QA\, validation\nSoftwa
 re development\n\nAnnex 11\n\nComparison with Part 11\n\nEU GDPR\n\nData 
 Privacy Statement\n\n\nFrequently Asked Questions:\n\n\nHow do you sugges
 t communicating to the vendor the importance of all versions (even minor)
  being validated prior to implementation?\nAll log ins and log outs must 
 be visible in audit log? even log outs due to inactivity?\nDoes Single Si
 gn On (SSO) capability go against the "passwords are not remembered" rule
 ?\nFor the new Data Privacy role will that be a QA or IT position?\nWhat 
 exactly is the validation that needs to occur each time my vendor deploys
  a minor and major release?\nHow can we get access to infrastructure qual
 ification templates?\nYou talked about data retention\, so is the data su
 pposed to be deleted or archived from a compliance perspective?\nDo you h
 ave any advice for validating software systems that were in place for man
 y years prior to being required to have validation reports?\n\nWho Will B
 enefit:\n\n\nGMP\, GCP\, GLP\, regulatory professionals\nQA/QC\nIT\nAudit
 ors\nManagers and directors\nSoftware vendors\, hosting providers\n
DTEND:20250205T113000
DTSTAMP:20260512T225913Z
DTSTART:20250205T100000
LOCATION:\,
SEQUENCE:0
SUMMARY:This 21 CFR Part 11 compliance training will guide you through the
  requirements of Part 11 and will also explain its 3 primary areas: SOPs\
 , product...
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