FDA Validation 2012 - GAMP® 5 as applied to FDA software validation - strategies to avoid warning letters

This GAMP® 5 training/Webinar will discuss on the GAMP® software validation model and the defined process of GAMP® 5 as it applied to FDA software validation.

Many companies struggle with understanding what FDA, MHRA, EU and other Ministries of Health want to see regarding software validation.This presentation will review the FDA validation process, the GAMP® software validation model, and the process defined in GAMP® 5 as it applies to FDA software validation. The attendee should leave the presentation confident in their ability to understand and apply the GAMP® 5 process.