Having a robust and functional Quality Management system is a QSR requirement for all Pharmaceutical,Biomedical,and Medical Device companies.This book does the following for you:1.It helps Managers in Startup companies design a Quality management system that meets and exceeds QSR requirements.2.It helps you understand requirements for the design of a Quality Management system for Medical Device,Pharmaceutical,Tissue,and Biomedical industries3.It provides the Quality system document structure4.It helps you understand Quality system requirements for ISO 13485,and ISO 90015.It provides standard definitions for the Quality management system6.It provides examples of Quality system related warning letters written by the FDA during onsite audits7.It provides the reader several models of a Quality Management system
Designing A World-Class Quality Management System For FDA...
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Book Description
Editorial Reviews
About the Author
David N.Muchemu is the author of "How to Design A World-Class Corrective Action and Preventive Action System for FDA regulated industries",and "Change Control for FDA Regulated Industries".Mr Muchemu has extensive experience in Pharmaceutical,Medical Device,Biomedical,and Tissue Industries.He has worked in different capacities at Boston Scientific,Johnson and Johnson,American Redcross Biomedical services,Guidant,Advanced Bionics , Applied Biosystems and Tissue Banks International.He is the founder of QSi (LLC),a Quality Management System/cGMP consulting firm in San Jose,California.
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Most Helpful Customer Reviews
6 of 6 people found the following review helpful:
1.0 out of 5 stars
Confusing,
By Denise Kirkman "QA Newbie" (Atlanta, GA) - See all my reviews
This review is from: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP (Hardcover)
I began reading this book as a newcomer to Quality Control Systems, expecting to be enlightened. However, I found lists with accompanying flowcharts that were inconsistent. For instance: "The model is comprised of the following subsections ..." followed by a list. The expanded explanation for these items is incomplete and in a
different order. There are "SEVEN MUST-HAVES" but I can't find what those are - there is no list with just seven elements. I tried simply reading it - with no understanding. Then I tried to make my own outline from the information and simply gave up because there was no structure that made sense to me. Abbreviations were given with no explanation, there were lists with items duplicated, and there were spelling errors. Words included in flow chart boxes were cut off, font sizes were inconsistent. Certainly not "WORLD-CLASS QUALITY" as advertised.
2.0 out of 5 stars
No connectivity between the contents at few chapters,
By SRJ (India) - See all my reviews
Amazon Verified Purchase(What's this?)
This review is from: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP (Paperback)
Not a very good book. There is no smooth flow of contents in few chapters. Editorial formatting also to be improved. Do not have any touch of professionalism
0 of 1 people found the following review helpful:
5.0 out of 5 stars
Howard Robinson,
By Howard Robison "Robbie" (San Fransisco,CA) - See all my reviews
This review is from: Designing A World-Class Quality Management System For FDA Regulated Industries: Quality System Requirements (QSR) For cGMP (Hardcover)
A very good read for Quality system professional in Pharma,Biomed,and Medical Device!
---A must read for those in cGMP organizations in trouble with the FDA! Howard.
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Inside This Book
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Key Phrases - Statistically Improbable Phrases (SIPs):
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quality subsystems, medical device organizations, design history file, subsystem policies, acceptance activities, quality management system, quality system requirements Key Phrases - Capitalized Phrases (CAPs): (learn more)
Class Quality Management System, Quality System Regulations Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
quality subsystems, medical device organizations, design history file, subsystem policies, acceptance activities, quality management system, quality system requirements Key Phrases - Capitalized Phrases (CAPs): (learn more)
Class Quality Management System, Quality System Regulations Browse Sample Pages:
Front Cover | Table of Contents | First Pages | Back Cover | Surprise Me!
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