Statistical Concepts of Process Validation - Webinar by GlobalCompliancePanel

9 January 2014, Fremont, United States

Introduction

The presentation concludes by showing the strong relationship between validated processes and Risk Management. ISO 14971:2007 requires that production (and post-production) information go back to Risk Assessment to help complete the life cycle. Validated processes, where the manufacturer cannot fully verify the output, present a risk of product "escape". Statistical information of each lot from a validated process should be part of the Risk Management File.