Full Description

The definitive text for quality and regulatory professionals. Each chapter includes three sections: a restatement of the relevant portion of the requirement, discussion of the requirement, and examples of industry practice. Developed through a consensus process with 30 GMP/Quality Systems experts from industry and FDA, this publication offers a broad understanding of the regulation and the means to achieve compliance. You will profit from the collective wisdom of years of experience from experts in all related disciplines. The Quality System Compendium is the basis for AAMI's highly regarded comprehensive course and exam, GMP/Quality System Requirements and Industry Practice.

Product Details

Published: 05/01/1998 Number of Pages: 175