Introduction to seminar - Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU General Data Protection Regulation (GDPR)

Duration: 30 Min
David Nettleton
David Nettleton FDA Compliance Specialist Computer System Validation

Computer System Validation's principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 280 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

This free webinar provides an overview of the regulatory requirements for 21 CFR Part 11, Annex 11, HIPAA, SaaS/Cloud hosted platforms, and EU General Data Protection Regulation (GDPR). It covers the four main areas of compliance: SOPs, software product features, infrastructure qualification, and software validation.

We will review the agenda for the two-day seminar, and have an interactive question and answer period with the instructor.

Target Audience:

Job title / designations

  • IT
  • QA/QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP, regulatory professionals
  • Software vendors, hosting providers
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