{"product_id":"gmp-audit-trainer-good-manufacturing-practices-made-easy-paperback","title":"GMP Audit Trainer: Good Manufacturing Practices Made Easy - Paperback","description":"\u003cp\u003eby \u003cb\u003eBrendan Cooper\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eBoth internal and external GMP audits\/inspections are a key requirement of Quality Management systems across medical device, biotechnology and pharmaceutical industries. Achieving a successful audit outcome is essential to maintaining an effective QMS and fundamental to retaining manufacturing licenses. In order to align systems and processes to ensure compliance and favorable audit outcomes personnel must understand the auditor focus and methodologies. This book summarises key areas that inspections cover along typical areas of risk and concern. The following chapters are included: Introduction to Good Manufacturing Preparation for Audits Inspection of Quality Systems During the Inspection, Biotechnology Inspection Guide, Medical Device Inspection Guide, Drugs Inspection Guide, Computerised Systems Inspection Guide, Validation of Hardware and Software, Electronic Records and Signatures Electronic Records Verification Methods\u003c\/p\u003e\u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 464\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.94 x 8.5 x 5.5 IN\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e July 07, 2017\u003c\/div\u003e","brand":"Books by splitShops","offers":[{"title":"Default Title","offer_id":47427351216306,"sku":"9781548711931","price":47.23,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0770\/3891\/1666\/files\/d7ada2b72130a9c172fcf35665eca76b.webp?v=1778522308","url":"https:\/\/box.dadyminds.org\/products\/gmp-audit-trainer-good-manufacturing-practices-made-easy-paperback","provider":"DADYMINDS BOX","version":"1.0","type":"link"}