David Muchemu

Designing a World-class Quality Management System for Fda Regulated Industries: Quality System Requirements (Qsr) for Cgmp David Muchemu

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 industries3. It provides the Quality system document structure4. It helps you understand Quality system requirements for ISO 13485,and ISO 90015. It provides standard definitions for the Quality management system6. It provides examples of Quality system related warning letters written by the FDA during onsite audits7. It provides the reader several models of a Quality Management system