{"product_id":"9781468522723","title":"Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP","description":"\u003cp\u003eHaving 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:\u003c\/p\u003e \u003cp\u003e1.It helps Managers in Startup companies design a Quality management system that meets and exceeds QSR requirements.\u003c\/p\u003e \u003cp\u003e2.It helps you understand requirements for the design of a  Quality Management system for Medical Device,Pharmaceutical,Tissue,and Biomedical industries\u003c\/p\u003e \u003cp\u003e3.It provides the Quality system  document structure\u003c\/p\u003e \u003cp\u003e4.It helps you understand Quality system requirements for ISO 13485,and ISO 9001\u003c\/p\u003e \u003cp\u003e5.It provides standard definitions for the Quality management system\u003c\/p\u003e \u003cp\u003e6.It provides examples of Quality system related warning letters written by the FDA during onsite audits\u003c\/p\u003e \u003cp\u003e7.It provides the reader several models of a Quality Management system\u003c\/p\u003e","brand":"AuthorHouse","offers":[{"title":"Default Title","offer_id":47141479874800,"sku":"9781468522723","price":3.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0737\/7593\/9824\/files\/9781468522723_p0.jpg?v=1763695431","url":"https:\/\/shop-qa.barnesandnoble.com\/products\/9781468522723","provider":"Barnes \u0026 Noble (DEV)","version":"1.0","type":"link"}