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

The purpose of Dr. D’s first book is to breakdown and analyze the requirements depicted in the 21 CFR, Part 820, also known as the FDA’s Quality System Regulation (QSR). The doctor tackles each of the sections of the QSR sequentially and hopes the readers are able to glean some useful information while enjoying the common-sense, objective, and no-nonsense approach to complying with each of the requirements.