Statistical Process Control for the FDA-Regulated Industry
eBook - ePub

Statistical Process Control for the FDA-Regulated Industry

  1. 204 pages
  2. English
  3. ePUB (mobile friendly)
  4. Available on iOS & Android
eBook - ePub

Statistical Process Control for the FDA-Regulated Industry

About this book

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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Yes, you can access Statistical Process Control for the FDA-Regulated Industry by Manuel E. Pena-Rodriguez in PDF and/or ePUB format, as well as other popular books in Technology & Engineering & Operations. We have over one million books available in our catalogue for you to explore.

Table of contents

  1. Statistical Process Control for the FDA-Regulated Industry
  2. Statistical Process Control for the FDA-Regulated Industry
  3. List of Figures and Tables
  4. Preface
  5. Chapter 1: Regulatory Importance of Statistical Process Control
  6. Chapter 2: SPC and the Life Sciences Regulated Industry
  7. Chapter 3: Process Variation
  8. Chapter 4: Basic Principles of Statistics
  9. Chapter 5: Graphical Tools
  10. Chapter 6: Measurement Systems Analysis
  11. Chapter 7: Process Capability
  12. Chapter 8: Hypothesis Testing
  13. Chapter 9: Regression Analysis
  14. Chapter 10: Design of Experiments
  15. Chapter 11: Control Charts
  16. Chapter 12: Final Thoughts
  17. Appendix A: Variable and Attribute Data Applications
  18. Appendix B: Applications for Various Graphical and Statistical Tools
  19. Appendix C: Basic Statistics for an Annual Product Review (APR) Report
  20. Appendix D: Most Commonly Used Hypothesis Tests
  21. Endnotes