{"product_id":"gmp-compliance-at-validation-qualification-parviz-bayegi-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\u003cb\u003eAuthor:\u003c\/b\u003e Parviz Bayegi\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 1447855108\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9781447855101\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Lulu.com\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 02\/07\/2023\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 222\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 0.87lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 10.00h x 7.00w x 0.47d","brand":"Parviz Bayegi","offers":[{"title":"Paperback","offer_id":46250586046719,"sku":"9781447855101","price":250.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/files\/img_3931b293-7c77-461e-806d-585d0395050e.jpg?v=1729600789","url":"https:\/\/www.whiterainbookhouse.com\/products\/gmp-compliance-at-validation-qualification-parviz-bayegi-9781447855101","provider":"WR Book House","version":"1.0","type":"link"}