How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR is a conference dedicated to the specific requirements associated with local and SaaS/cloud hosting solutions.

How to be efficient and compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR covers topics such as:

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

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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