ABSTRACT

Written especially for the pharmaceutical industry professional, this book addresses each part of the life-cycle of engineering change control. It covers issues in the EU and US and describes the operational requirements and responsibilities that ensure change controls are effectively applied and recorded. Providing guidance on how to demonstrate t

chapter 1|14 pages

Change Is Inevitable - Why?

chapter 3|14 pages

A Regulatory View - EU

chapter 4|18 pages

The Operational Phase

chapter 5|24 pages

The Change Control System

chapter 6|30 pages

Change Control and Computer Systems

chapter 7|26 pages

Case Histories and Anecdotes

chapter 8|16 pages

Projects