Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
612-822-4611

  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates: for Pharma / Biotech / ATMP / Medical Device

GMP Compliance at Validation, Qualification & Documentation with practical case studies and templates: for Pharma / Biotech / ATMP / Medical Device

Bayegi, Parviz

Paperback

Medical Reference

ISBN10: 1447855108
ISBN13: 9781447855101
Publisher: Lulu Pr
Published: Feb 7 2023
Pages: 222
Weight: 0.87
Height: 0.47 Width: 7.00 Depth: 10.00
Language: English
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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