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What exactly is required for 21 CFR Part 11, SaaS/Cloud, EU GDPR - Webinar

  • ID: 4755609
  • Webinar
  • 90 Minutes
  • World Compliance Seminar
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This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.
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Which data and systems are subject to Part 11 and Annex 11
  • How to write a Data Privacy Statement
  • What the regulations mean, not just what they say
  • Avoid 483 and Warning Letters
  • Requirements for local, SaaS, and cloud hosting
  • Understand the current industry standard software features for security, data transfer, audit trails, and electronic signatures
  • How to use electronic signatures, ensure data integrity, and protect intellectual property
  • SOPs required for the IT infrastructure
  • Product features to look for when purchasing COTS software
  • Reduce validation resources by using easy to understand fill-in-the-blank validation documents
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  • David Nettleton David Nettleton,


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  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors
  • hosting providers
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