FDA's New Enforcement Practices of 21 CFR Part 11 - Webinar By GlobalCompliancePanel

26 July 2012, Wilmington, United States

Introduction

Overview: Within the next few weeks and months the FDA will continue to conduct a series of Part 11 related inspections. Planned routine inspections will be extended to evaluate the companies' practices to ensure integrity, authenticity and availability of electronic records, The program is the long awaited next step for Part 11 and nevertheless it came as a surprise to the industry.