21 CFR Part 11 Compliance for SaaS/Cloud Applications

21 CFR Part 11 Compliance for SaaS/Cloud Applications is a seminar that covers topics such as:

  • Reduce costs, usually by two-thirds, for compliance with electronic records
  • Learn how to use electronic records and electronic signatures to maximize productivity
  • Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
  • Avoid 483 and Warning Letters
  • Understand the responsibilities and specific duties of your staff including IT and QA
  • Understand your responsibilities and liabilities when using SaaS/cloud
  • Learn how HIPAA expands Part 11 compliance
  • Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
  • How to select resources and manage validation projects
  • "Right size" change control methods that allows quick and safe system evolution
  • Minimize validation documentation to reduce costs without increasing regulatory or business risk
  • Learn how to reduce testing time and write test cases that trace to elements of risk management
  • Learn how to comply with the requirements for data privacy
  • Learn how to buy COTS software and qualify vendors
  • Protect intellectual property and keep electronic records safe

21 CFR Part 11 Compliance for SaaS/Cloud Applications brings together attendees from health care, clinical trial, biopharmaceutical, and medical device sectors, including:

  • GMP, GCP, GLP, regulatory professionals
  • QA/QC
  • IT
  • Auditors
  • Managers and directors
  • Software vendors, SaaS hosting providers

Future Events

21 CFR Part 11 Compliance for SaaS/Cloud Applications 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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