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

af Parviz Bayegi
GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates af Parviz Bayegi
Bag 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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  • Sprog:
  • Engelsk
  • ISBN:
  • 9781447855101
  • Indbinding:
  • Paperback
  • Sideantal:
  • 222
  • Udgivet:
  • 7. februar 2023
  • Størrelse:
  • 178x12x254 mm.
  • Vægt:
  • 427 g.
  • 8-11 hverdage.
  • 20. november 2024
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  • BLACK NOVEMBER

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Prøv i 30 dage for 45 kr.
Herefter fra 79 kr./md. Ingen binding.

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Beskrivelse af 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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