Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical, Biomedical, and Medical Device companies.This book does the following for you: 1.It helps Managers in Startup companies 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 provides examples of Quality system related warning letters written by the FDA during onsite audits 7.It provides the reader several models of a Quality Management system1.2 Avante Medical Productsa#39; quality management system is designed to meet the following quality standards and requirements, 1.2.1 ISO13485: ... In this section specify the number of quality manuals available and where they are located.
|Title||:||Designing A World-Class Quality Management System For FDA Regulated Industries|
|Author||:||David N. Muchemu|
|Publisher||:||AuthorHouse - 2008-04-07|