GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates
for Pharma / Biotech / ATMP / Medical Device
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This book offers understandable introductions to the GMP technical basics and concepts for validation & 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? ...
This book offers understandable introductions to the GMP technical basics and concepts for validation & 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 & 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
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