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  5. GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates

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

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

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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  • Språk:
  • Engelska
  • ISBN:
  • 9781447855101
  • Format:
  • Häftad
  • Sidor:
  • 222
  • Utgiven:
  • 7. februari 2023
  • Mått:
  • 178x12x254 mm.
  • Vikt:
  • 427 g.
  Fri leverans
Leveranstid: 2-4 veckor
Förväntad leverans: 18. december 2024

Om Parviz Bayegi

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Beskrivning av GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates

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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