Statistical Process Control for the FDA-Regulated Industry

Manuel E. Pena-Rodriguez

• Publisher: ASQ Quality Press
• Year: 2013
• ISBN:
  9781953079800
• Edition: 1
• Topic: Tecnología e ingeniería
• Subtopic: Control de calidad en ingeniería

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.

Table of contents

• Statistical Process Control for the FDA-Regulated Industry
• Statistical Process Control for the FDA-Regulated Industry
• 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