Statistical Process Control for the FDA-Regulated Industry PDF Download
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Author: Manuel E. Pena-Rodriguez
Publisher: Quality Press
ISBN: 0873898524
Category : Business & Economics
Languages : en
Pages : 205
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Book Description
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 authors 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.
Author: Manuel E. Pena-Rodriguez
Publisher: Quality Press
ISBN: 0873898524
Category : Business & Economics
Languages : en
Pages : 205
Get Book Here
Book Description
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 authors 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.
Author: José Rodríguez-Pérez
Publisher: Quality Press
ISBN: 1953079326
Category : Business & Economics
Languages : en
Pages : 252
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Book Description
The purpose of this new edition is to offer an updated view of the risk management field as it applies to medical products. Since the publication of the first edition (2012), the emphasis on risk-based processes has growth exponentially across all sectors, and risk management is now considered as significant as quality management. ISO 9001 was revised and now requires that top management promote the use of risk-based thinking. ISO 13485:2016, which specifies the requirements for a quality management system specific to the medical devices industry, also now shows a greater emphasis on risk management and risk-based decision making. In addition, the FDA Food Safety Modernization Act (FSMA) is the most important reform of U.S. food safety laws in more than 70 years. This indispensable book presents a systematic and comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practice or good laboratory practice. All chapters have been updated and revised, and a new chapter has been added to discuss some of the most common pitfalls and misunderstandings regarding risk management, specifically those related to the use of FMEA as the only element of risk management programs. One of the appendices includes 12 case studies, and the companion CD-ROM contains dozens of U.S. FDA and European guidance documents as well as international harmonization documents (ICH and GHTF-IMDRF) related to risk management activities, as well as a 30-question exam (with answers) on the material discussed in the book.
Author: José Rodríguez Pérez
Publisher: Quality Press
ISBN: 0873898346
Category : Business & Economics
Languages : en
Pages : 289
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Book Description
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
Author: Jose (Pepe) Rodriguez-Perez
Publisher: Quality Press
ISBN: 1636941575
Category : Business & Economics
Languages : en
Pages : 293
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Book Description
For quality professionals and manufacturers in the food safety and medical device industries, risk management is essential to ensuring organizations meet FDA regulations and requirements. Without these recognized standards, the lives of patients and consumers are placed in jeopardy. In this third edition of Quality Risk Management in the FDA-Regulated Industry, Jose Rodriguez-Perez provides an updated view of the risk management field as it applies to FDA-regulated products using risk-based thinking.
Author: Leonard A. Doty
Publisher: Industrial Press Inc.
ISBN: 9780831130695
Category : Business & Economics
Languages : en
Pages : 396
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Book Description
This in-depth introduction to SPC examines the technical aspects of the practices and procedures that are used to apply the quality management system in manufacturing. As in the successful first edition, the author provides a description and history of SPC along with an analysis of how it is applied to control quality costs, productivity, product improvement, and work efficiency. New to this edition are an explanation of seven basic tools, new charts, and an exploration of current trends.
Author: Robert James Oakland
Publisher: Routledge
ISBN: 1351662686
Category : Business & Economics
Languages : en
Pages : 430
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Book Description
The business, commercial and public-sector world has changed dramatically since John Oakland wrote the first edition of Statistical Process Control – a practical guide in the mid-eighties. Then people were rediscovering statistical methods of ‘quality control’ and the book responded to an often desperate need to find out about the techniques and use them on data. Pressure over time from organizations supplying directly to the consumer, typically in the automotive and high technology sectors, forced those in charge of the supplying production and service operations to think more about preventing problems than how to find and fix them. Subsequent editions retained the ‘took kit’ approach of the first but included some of the ‘philosophy’ behind the techniques and their use. The theme which runs throughout the 7th edition is still processes - that require understanding, have variation, must be properly controlled, have a capability, and need improvement - the five sections of this new edition. SPC never has been and never will be simply a ‘took kit’ and in this book the authors provide, not only the instructional guide for the tools, but communicate the management practices which have become so vital to success in organizations throughout the world. The book is supported by the authors' extensive and latest consulting work within thousands of organisations worldwide. Fully updated to include real-life case studies, new research based on client work from an array of industries, and integration with the latest computer methods and Minitab software, the book also retains its valued textbook quality through clear learning objectives and end of chapter discussion questions. It can still serve as a textbook for both student and practicing engineers, scientists, technologists, managers and for anyone wishing to understand or implement modern statistical process control techniques.
Author: Merton R. Hubbard
Publisher: Springer Science & Business Media
ISBN: 1461501490
Category : Technology & Engineering
Languages : en
Pages : 347
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Book Description
Specifically targeted at the food industry, this state-of-the-art text/reference combines all the principal methods of statistical quality and process control into a single, up-to-date volume. In an easily understood and highly readable style, the author clearly explains underlying concepts and uses real world examples to illustrate statistical techniques. This Third Edition maintains the strengths of the first and second editions while adding new information on Total Quality Management, Computer Integrated Management, ISO 9001-2002, and The Malcolm Baldrige Quality Award. There are updates on FDA Regulations and Net Weight control limits, as well as additional HACCP applications. A new chapter has been added to explain concepts and implementation of the six-sigma quality control system.
Author: Gordon Harnack
Publisher: Quality Press
ISBN: 1636940463
Category : Business & Economics
Languages : en
Pages : 501
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Book Description
The number of FDA regulations and the agency’s increased expectations is staggering and their content tedious, creating a regulated industry need for compliance insight and appropriate detail. This book is the reference needed to successfully navigate through the FDA maze! The target audiences for this desk reference include: Regulatory professionals, who know their responsibility to keep their firm’s employees trained and competent on FDA device regulations and who need a preliminary desk reference that can be used throughout their enterprise to help train and ensure compliance Neophytes, who know nothing about FDA but need a resource that provides both broad and specific information in sufficient detail to be useful Beginners, who know a little about FDA, need to know more, and need a reference tool to help them be more effective and productive on the job Intermediates, who knows enough about FDA to know they need to know more and who need a reference tool that provides them with both more basics and executable detail Busy managers, who need to know regulatory requirements and FDA expectations in order to manage compliance in their specific activity Busy executives (CEOs, COOs, and operations managers, whom FDA holds responsible for all regulatory compliance), who also need a desk reference with specific information to quickly assess regulatory compliance, identify potential noncompliance, and review corrective, preventive, and compliance actions
Author: Mark Allen Durivage
Publisher: Quality Press
ISBN: 1636941028
Category : Business & Economics
Languages : en
Pages : 135
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Book Description
For the past decade, process validation issues ranked within the top six of Food and Drug Administration (FDA) form 483 observation findings issued each year. This poses a substantial problem for the medical device industry and is the reason why the authors wanted to write this book. The authors will share their collective knowledge: to help organizations improve patient safety and increase profitability while maintaining a state of compliance with regulations and standards. The intent of this book is to provide manufacturing quality professionals working in virtually any industry a quick, convenient, and comprehensive guide to properly conduct process validations that meet regulatory and certification requirements. It will aid quality technicians, engineers, managers, and others that need to plan, conduct, and monitor validation activities.
Author: James Evans
Publisher: Pearson Education
ISBN: 0132442019
Category : Technology & Engineering
Languages : en
Pages : 231
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Book Description
With today's growing emphasis on quality improvement, training individuals in fundamental quality control skills is a major challenge. Professionals in manufacturing industries need to bring processes into statistical control – and maintain them. This book is designed to help readers learn the statistical tools and concepts needed to develop and use quality control effectively.
