Statistical Process Control For The Fda Regulated Industry

Author : Manuel E. Pena-Rodriguez
Publisher : Quality Press
ISBN 13 : 0873898524
Total Pages : 205 pages
Book Rating : 4.22/5 ( download)

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Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-11 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : Manuel E. Pena-Rodriguez
Publisher : Quality Press
ISBN 13 : 1953079806
Total Pages : 205 pages
Book Rating : 4.00/5 ( download)

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Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-14 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Author : David N. Muchemu
Publisher : AuthorHouse
ISBN 13 : 1434314685
Total Pages : 150 pages
Book Rating : 4.80/5 ( download)

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Download or read book Change Control for FDA Regulated Industries written by David N. Muchemu and published by AuthorHouse. This book was released on 2007 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book accomplishes the following: .It addresses requirements for Pharmaceutical, Medical Device, Biologics, and Tissue banking change control .Defines the different phases of the change control life cycle .Establishes the relationship between risk management, cost of doing business and change control .Defines regulatory requirements for change control, including requirements for (510k) submission .Provides tools for risk assesment, and cost/benefit analysis .Helps the reader design a Change control system that meets and exceeds cGMP requirements

Author : José Rodríguez-Pérez
Publisher : Quality Press
ISBN 13 : 1953079326
Total Pages : 252 pages
Book Rating : 4.29/5 ( download)

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Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2017-02-21 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Jose (Pepe) Rodriguez-Perez
Publisher : Quality Press
ISBN 13 : 1636941567
Total Pages : 313 pages
Book Rating : 4.61/5 ( download)

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Download or read book Quality Risk Management in the FDA-Regulated Industry written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2024-04-18 with total page 313 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Gordon Harnack
Publisher : Quality Press
ISBN 13 : 1636940463
Total Pages : 501 pages
Book Rating : 4.65/5 ( download)

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Download or read book Mastering and Managing the FDA Maze written by Gordon Harnack and published by Quality Press. This book was released on 2014-07-18 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 1636941028
Total Pages : 135 pages
Book Rating : 4.28/5 ( download)

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Download or read book Practical Process Validation written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-07-11 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Sarina A. Lim
Publisher : John Wiley & Sons
ISBN 13 : 1119152003
Total Pages : 188 pages
Book Rating : 4.02/5 ( download)

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Download or read book Statistical Process Control for the Food Industry written by Sarina A. Lim and published by John Wiley & Sons. This book was released on 2019-02-25 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive treatment for implementing Statistical Process Control (SPC) in the food industry This book provides managers, engineers, and practitioners with an overview of necessary and relevant tools of Statistical Process Control, a roadmap for their implementation, the importance of engagement and teamwork, SPC leadership, success factors of the readiness and implementation, and some of the key lessons learned from a number of food companies. Illustrated with numerous examples from global real-world case studies, this book demonstrates the power of various SPC tools in a comprehensive manner. The final part of the book highlights the critical challenges encountered while implementing SPC in the food industry globally. Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers explores the opportunities to deliver customized SPC training programs for local food companies. It offers insightful chapter covering everything from the philosophy and fundamentals of quality control in the food industry all the way up to case studies of SPC application in the food industry on both the quality and safety aspect, making it an excellent "cookbook" for the managers in the food industry to assess and initiating the SPC application in their respective companies. Covers concise and clear guidelines for the application of SPC tools in any food companies' environment Provides appropriate guidelines showing the organizational readiness level before the food companies adopt SPC Explicitly comments on success factors, motivations, and challenges in the food industry Addresses quality and safety issues in the food industry Presents numerous, global, real-world case studies of SPC in the food industry Statistical Process Control for the Food Industry: A Guide for Practitioners and Managers can be used to train upper middle and senior managers in improving food quality and reducing food waste using SPC as one of the core techniques. It's also an excellent book for graduate students of food engineering, food quality management and/or food technology, and process management.

Author : Heather Crawford
Publisher : Quality Press
ISBN 13 : 0873899628
Total Pages : 300 pages
Book Rating : 4.28/5 ( download)

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Download or read book The Biomedical Quality Auditor Handbook, Third Edition written by Heather Crawford and published by Quality Press. This book was released on 2017-09-08 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Biomedical Quality Auditor Handbook was developed by the ASQ Biomedical Division in support of its mission to promote the awareness and use of quality principles, concepts, and technologies in the biomedical community. This third edition correlates to the 2013 exam Body of Knowledge (BoK) and reference list for ASQ’s Certified Biomedical Auditor program. It includes updates and corrections to errors and omissions in the second edition. Most notably it has been re-organized to align more closely with the BoK.

Author : Mark Allen Durivage
Publisher : Quality Press
ISBN 13 : 1951058909
Total Pages : 404 pages
Book Rating : 4.06/5 ( download)

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Download or read book The Certified Pharmaceutical GMP Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.