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