{"product_id":"gmp-and-gxp-guide-for-engineers-quality-compliance-and-inspection-paperback","title":"GMP and GXP Guide for Engineers: Quality, Compliance and Inspection - Paperback","description":"\u003cp\u003eby \u003cb\u003ePriscilla Browne\u003c\/b\u003e (Author)\u003c\/p\u003e\u003cp\u003eThe GMP and GXP Guide for Engineers brings together regulatory guidance and industry norms into a paperback resource for Engineers and professionals working in Life Sciences (Medical devices, Pharamceutical and Biotechnology). It is a powerful resource for those looking to refresh knowledge or those who wish to have a practical resource at their fingertips. The title is divided into five comprehensive chapters.Chapter 1-Good Manufacturing Practices (GMP): This chapter reviews the body of guidance and regulations on GMP published by the FDA, PICs, EU GMP and WHO. It will provide the reader with a broad understanding of what is required to meet GMP in a manufacturing setting.Chapter 2-Data Integrity, reviews the increasingly critical area of Data and ensuring data reliability and integrity in a CGMP setting.Chapter 3-Test Method Validation, takes the reader through the fundamentals of TMV. Chapter 4-Cleaning and GMP, provides an overview of a process approach to cleaning along with an explanation of key concepts. In conclusion, Chapter 5-Audit and Inspection Guide, examines auditor approaches and key focus areas on what is expected for onsite inspection. (Large Paperback 8\" X 10\", 310 pages)\u003c\/p\u003e\u003cdiv\u003e\n\u003cstrong\u003eNumber of Pages:\u003c\/strong\u003e 314\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003eDimensions:\u003c\/strong\u003e 0.66 x 10 x 8 IN\u003c\/div\u003e\u003cdiv\u003e\n\u003cstrong\u003ePublication Date:\u003c\/strong\u003e August 09, 2017\u003c\/div\u003e","brand":"Books by splitShops","offers":[{"title":"Default Title","offer_id":51795730792736,"sku":"9781974426270","price":26.98,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0974\/9764\/5344\/files\/06b72e16614aeb6d49e150ae580ef766.webp?v=1780746645","url":"https:\/\/ebocreations.com\/products\/gmp-and-gxp-guide-for-engineers-quality-compliance-and-inspection-paperback","provider":"The E-Book Oasis LLC","version":"1.0","type":"link"}