{"product_id":"9781447855101","title":"Gmp Compliance At Validation, Qualification \u0026 Documentation With Practical Case Studies And Templates: For Pharma \/ Biotech \/ Atmp \/ Medical Device","description":"This book offers understandable introductions to the GMP technical basics and concepts for validation \u0026amp; qualification of projects in the areas of Pharma \/ Biotech \/ ATMP \/ Medical Device. The necessary specialist knowledge about GMP guidelines (validation\/qualification\/documentation) was made easily and understandably accessible via example and simulated projects. Topics in this book are: - What is qualification, and what is validation? - Why am I qualifying? - How do I start with a GMP concept\/project? - What are my GMP qualification strategies? - How do I write a project risk analysis? - What is change control (CC) and do I need a master or sub CC? - How do I write a Validation Master Plan (VMP)? - What is an FMEA, and why do I need an FMEA? - How do I write an FMEA? - How do I write a qualification plan (QP)? - What are FAT \u0026amp; SAT? And do I need these tests? - How do I create qualification documents (DQ, IQ, OQ, PQ)? - Step-by-step validation and qualification using case studies\u003cbr\u003e\u003cbr\u003e\u003cbr\u003e\u003cul\u003e\n\u003cli\u003e| \u003cb\u003eAuthor: \u003c\/b\u003eParviz Bayegi\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003ePublisher: \u003c\/b\u003eLulu.Com\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003ePublication Date: \u003c\/b\u003eFeb 07, 2023\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eNumber of Pages: \u003c\/b\u003e221 pages\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eLanguage: \u003c\/b\u003eEnglish\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eBinding: \u003c\/b\u003ePaperback\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eISBN-10: \u003c\/b\u003e1447855108\u003c\/li\u003e\n\u003cli\u003e| \u003cb\u003eISBN-13: \u003c\/b\u003e9781447855101\u003c\/li\u003e\n\u003c\/ul\u003e","brand":"Lulu.Com","offers":[{"title":"Default Title","offer_id":47571187761457,"sku":"9781447855101","price":261.94,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0798\/8215\/8385\/products\/9781447855101.jpg?v=1697735215","url":"https:\/\/www.recomparo.com\/products\/9781447855101","provider":"ReComparo.com","version":"1.0","type":"link"}