GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates - Bayegi, Parviz

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Résumé :
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...

Biographie:
www.bayegi.com...

Sommaire:
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...