Statistical Process Control for the FDA-Regulated Industry

Title: Statistical Process Control for the FDA-Regulated Industry
Author: Manuel E. Pena-Rodriguez
ISBN: 0873898524 / 9780873898522
Format: Hard Cover
Pages: 204
Publisher: ASQ
Year: 2013
Availability: Out of Stock

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The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA.

This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry.

Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author’s almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.

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List of Figures and Tables
Preface

Chapter 1 : Regulatory Importance of Statistical Process Control
Chapter 2 : SPC and the Life Sciences Regulated Industry
Chapter 3 : Process Variation
Chapter 4 : Basic Principles of Statistics
Chapter 5 : Graphical Tools
Chapter 6 : Measurement Systems Analysis
Chapter 7 : Process Capability
Chapter 8 : Hypothesis Testing
Chapter 9 : Regression Analysis
Chapter 10 : Design of Experiments
Chapter 11 : Control Charts
Chapter 12 : Final Thoughts

Appendix A : Variable and Attribute Data Applications
Appendix B : Applications for Various Graphical and Statistical Tools
Appendix C : Basic Statistics for an Annual Product Review (APR) Report
Appendix D : Most Commonly Used Hypothesis Tests
Endnotes
Index