Devine Guidance for Complying with the FDA’S Quality System Regulation: 21 CFR, Part 820

This is a great book if you are new to the CFR Part 820, there are recommendations on how to handle the process, implementation, and it discusses fda warnings etc. If you are implementing or don't stay up on the fda website as to what is going on, then I would recommend this to you.I audit our suppliers to CFR 820 so if I find large gaps when auditing I recommend this book, and one other book to our suppliers.

OK. Takes a very boring and tedious subject and makes it slightly less so. The author, Mr. Devine, does make many good points from his experiences in the field. Overall, it is a good book.

This book was a lifesaver! I needed a crash course on 21 CFR part 820 requirements to prepare for a mock FDA inspection. I ordered other books but found Chris' book the most helpful. It covers the important points of each element in a direct, easy-to-understand format. I completely used up a highlight marker while reading his book cover-to-cover, creating a comprehensive audit checklist in the process. Thank you Chris!

The part of warning letter is very good to understand the point of inspector's view. Except for this, no heads-up come up to me.

good

This book should be considered as a first introduction to the QSR for QA/QE new in the field (I would say, less than 1year experience). Now I explain you why.It is organized as the QSR. For each chapter the author gives: examples of warning letters, 483 observations and then the explanation of the topic.However, the explanations are very basic,and the suggestions repetitive (for instance, the need for SOP, this is really trivial but repeated with great enphasis for several times in each chapter, wasting a lot of space and making the reader bored). You will never find a structured approach for a topic, for instance, on how to organize a complaint management system in your company or a CAPA system. You will never find a diagram for the interaction between the different requirements.Moreover, when you buy this book, consider that the line spacing is huge, so the effective information are much reduced.Final remark: As said at the beginning, buy this book ONLY if new in the field, to have a general impression. Then, I suggest you to buy a more advanced book (like the AAMI compendium), which is however 20 times more expensive than this one.I gave 3/5 stars for the price, otherwise would have been 2/5.A suggestion to the author would be to prepare a 2nd edition.

The content of this resource was not very valuable. A Quality Engineer would gain more from reading 21 CFR 820 than this book.

This book floats among the Quality Team at my office. We flip through it once in a while. There are some good points, but I'm not impressed. One major weakness is the lack of an index.