{"product_id":"gmp-compliance-at-validation-qualification-documentation-with-practical-case-studies-and-templates","title":"GMP Compliance at Validation, Qualification \u0026 Documentation with practical case studies and templates","description":"\u003cp\u003eThis 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.\u003cbr\u003e\nThe necessary specialist knowledge about GMP guidelines (validation\/qualification\/documentation) was made easily and understandably accessible via example and simulated projects.\u003cbr\u003e\nTopics in this book are:\u003cbr\u003e\n¥ What is qualification, and what is validation?\u003cbr\u003e\n¥ Why am I qualifying?\u003cbr\u003e\n¥ How do I start with a GMP concept\/project? ¥\u003cbr\u003e\n  What are my GMP qualification strategies?\u003cbr\u003e\n¥ How do I write a project risk analysis?\u003cbr\u003e\n¥ What is change control (CC) and do I need a master or sub CC?\u003cbr\u003e\n¥ How do I write a Validation Master Plan (VMP)?\u003cbr\u003e\n¥ What is an FMEA, and why do I need an FMEA?\u003cbr\u003e\n¥ How do I write an FMEA?\u003cbr\u003e\n¥ How do I write a qualification plan (QP)?\u003cbr\u003e\n¥ What are FAT \u0026amp; SAT? And do I need these tests?\u003cbr\u003e\n¥ How do I create qualification documents (DQ, IQ, OQ, PQ)?\u003cbr\u003e\n¥ Step-by-step validation and qualification using case studies\u003c\/p\u003e","brand":"BooksWholesale","offers":[{"title":"Paperback","offer_id":44274599198881,"sku":"9781447855101","price":270.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0462\/1120\/3233\/files\/yp9rg9-front-shortedge-384.jpg?v=1714068820","url":"https:\/\/bookswholesale.myshopify.com\/products\/gmp-compliance-at-validation-qualification-documentation-with-practical-case-studies-and-templates","provider":"BooksWholesale","version":"1.0","type":"link"}