Computer System Validation Webinar:
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.
(2-hour on-line Session)
Validation Introduction – the What & Why
Validation Process Overview
Validation File Documentation
FDA Expectations – 483s and Warning Letters