Prepare for FDA CSV Inspections – Review of Recent Enforcement Actions, 483’s and Warning Letters

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The FDA has been expanding their audit programs and the number of observations related to validation problems has been steadily increasing. New requirements for Risk Assessments have been appearing, as well as a number of observations related to change control This session will focus on what the agency is looking for in your validation program by reviewing recent 483’s and warning letters related to computer system validations. Key points that will be covered include:

  • Current FDA Requirements and Expectations for Validation
  • Review of recent 483’s and Warning letters
  • Consequences of Validation Gaps
  • A checklist of the top observations to avoid

Presented by Tyson M. Mew, President, Ofni Systems, Inc.
11th Annual Computer and Software Validation
Presented by IVT