Designing a World-Class Quality Management System for FDA Regulated Industries: Quality System Requirements (Qsr) for Cgmp

by David N. Muchemu

This book accomplishes the following for 1.It helps you design a Quality management system that meets and exceeds QSR requirements. 2.It helps you understand requirements for the design of a Quality Management system for Medical Device, Pharmaceutical, Tissue, and Biomedical industries 3.It provides the Quality system document structure 4.It helps you understand Quality system requirements for ISO 13485, and ISO 9001 5.It provides standard definitions for the Quality management system 6.It gives you examples of Quality system related warning letters written by the FDA during onsite audi

132 pages, Hardcover

First published April 5, 2008