Manuel E. Pena-Rodriguez

Statistical Process Control for the FDA-Regulated Industry (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, D ausgeliefert werden.

Produktdetails

• Verlag: ASQ Quality Press
• Seitenzahl: 204
• Erscheinungstermin: 14. April 2013
• Englisch
• ISBN-13: 9781953079800
• Artikelnr.: 67328479

Autorenporträt

Manuel E. Peña Rodríguez is a process improvement and training consultant with more than 25 years of experience in many industry sectors. Since January 2006, he is fully devoted to consulting under Business Excellence Consulting Inc. He also served as professor in the graduate program in biochemistry at the University of Puerto Rico, Medical Sciences Campus, in San Juan PR. Mr. Peña Rodríguez received his Juris Doctor degree from the Pontifical Catholic University of Puerto Rico and his Master of Engineering in Engineering Management degree from Cornell University in Ithaca NY. He is also a licensed Professional Engineer registered in Puerto Rico and an attorney registered in the Supreme Court of Puerto Rico and the U.S. District Court for the District of Puerto Rico. Mr. Peña Rodríguez is an ASQ Certified Six Sigma Black Belt, Manager of Quality & Organizational Excellence, Quality Engineer, Quality Auditor, Medical Device Auditor, and Food Safety & Quality Auditor. He is also a Senior member of ASQ and former Chair of the Puerto Rico ASQ Section. He is the author of the books "Statistical Process Control for the FDA- Regulated Industry" and "Process Monitoring and Improvement Handbook", published by ASQ Quality Press. His most recent textbooks are "Effective Internal Auditing" and "Effective Compliance and Regulatory Writing", published by BEC Press. Mr. Peña Rodríguez is also the author of the article "Serious About Samples: Understanding Different Approaches for Process Monitoring and When to Use Them" and co-author (with José Rodríguez-Pérez) of the articles "Fail- Safe FMEA", "CAPA Pitfalls and Pratfalls", and "Essential Evaluation". All those articles were published in the monthly editions of the ASQ Quality Progress magazine.