Customer Reviews

Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP

5 star:		(1)
4 star:		(0)
3 star:		(0)
2 star:		(1)
1 star:		(1)

 

 

I began reading this book as a newcomer to Quality Control Systems, expecting to be enlightened. However, I found lists with accompanying flowcharts that were inconsistent. For instance: "The model is comprised of the following subsections ..." followed by a list. The expanded explanation for these items is incomplete and in a
different order. There are "SEVEN MUST-HAVES" but I can't find what those are - there is no list with just seven elements.

I tried simply reading it - with no understanding. Then I tried to make my own outline from the information and simply gave up because there was no structure that made sense to me.

Abbreviations were given with no explanation, there were lists with items duplicated, and there were spelling errors. Words included in flow chart boxes were cut off, font sizes were inconsistent.

Certainly not "WORLD-CLASS QUALITY" as advertised.

Not a very good book. There is no smooth flow of contents in few chapters. Editorial formatting also to be improved. Do not have any touch of professionalism

A very good read for Quality system professional in Pharma,Biomed,and Medical Device!
---A must read for those in cGMP organizations in trouble with the FDA!
Howard.