Computer System Validation Overview Webinar


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This 2-hour introductory session overviews the regulatory and business requirements for computer system validation in FDA-regulated industries. It includes a discussion of the issues surrounding the validation effort, and reviews the scope of the validation activities. The Registration Fee includes attendance, presentation slides, and session handouts.

Additional information

Dates Offered:

May 17, 2017 (1:00 to 3:00 PM EDT) On-line/Telephone, September 20, 2017 (1:00 to 3:00 PM EDT) On-line/Telephone, December 07, 2017 (1:00 to 3:00 PM EDT) On-line/Telephone

(2-hour on-line Session)

  • Validation Introduction – the What & Why
  • Validation Process Overview
  • Validation File Documentation
  • Change Management
  • FDA Expectations – 483s and Warning Letters