Change Control for FDA Regulated Industries: A Risk Assesment Approach Hardcover – October 13, 2007

Whilst I did take away a couple of useful points (hence the two stars), overall it is possibly the worst edited and most inconsistent book I've ever read. Occasionally the author will contradict himself in the same sentence: "The initiation phase has four processes in it: change request initiation, risk analysis, impact analysis, validation, and stakeholder analysis".... so five then? These sort of contradictions and inconsistent terminology are prevalent throughout the book. You get the feeling that the author probably does have a relatively good grip of the subject, but has either written it very poorly or needs to have serious words with his publishers.