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Statistical Process Control For The Fda Regulated Industry
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Book Synopsis Statistical Process Control for the FDA-Regulated Industry by : Manuel E. Pena-Rodriguez
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 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.
Book Synopsis Statistical Process Control by : Robert James Oakland
Download or read book Statistical Process Control written by Robert James Oakland and published by Routledge. This book was released on 2018-10-08 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez-Pérez
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.
Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : Jose (Pepe) Rodriguez-Perez
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 293 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.
Book Synopsis Statistical Process Control by : Leonard A. Doty
Download or read book Statistical Process Control written by Leonard A. Doty and published by Industrial Press Inc.. This book was released on 1996 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals by : José Rodríguez-Pérez
Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.
Book Synopsis The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries by : T Cochrane
Download or read book The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries written by T Cochrane and published by Elsevier. This book was released on 2029-01-01 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Innovative new technology now allows the measurement and collection of data throughout many manufacturing processes previously unavailable. The The Application of Statistical Process Control in the Pharmaceutical and Biotechnology Industries is a starting point for anyone who has been tasked to use technology to measure and collect data to gain an understanding of their processes in order to improve and control lengthy, complex supply chains in the pharmaceutical industry. It is a practical guide on how to apply statistical process control (SPC) within the pharmaceutical industry. It encourages all those involved in the industry - whether it be production, quality or the regulatory bodies - to start assessing data in a different way. This book delivers a way of viewing data that is both simple and easy to understand and relates to our understanding of the world in which we work. The first book to describe SPC in the pharmaceutical and biotechnology industries Highly practical approach Contains many case studies showing the application of SPC
Book Synopsis Statistical Quality Control for the Food Industry by : Merton R. Hubbard
Download or read book Statistical Quality Control for the Food Industry written by Merton R. Hubbard and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Mastering and Managing the FDA Maze by : Gordon Harnack
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
Book Synopsis Practical Process Validation by : Mark Allen Durivage
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.
Book Synopsis Statistical Process Control For Quality Improvement by : James Evans
Download or read book Statistical Process Control For Quality Improvement written by James Evans and published by Pearson Education. This book was released on 1991-03-29 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Introduction to Statistical Process Control by : Muhammad Aslam
Download or read book Introduction to Statistical Process Control written by Muhammad Aslam and published by John Wiley & Sons. This book was released on 2020-09-16 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: An Introduction to the Fundamentals and History of Control Charts, Applications, and Guidelines for Implementation Introduction to Statistical Process Control examines various types of control charts that are typically used by engineering students and practitioners. This book helps readers develop a better understanding of the history, implementation, and use-cases. Students are presented with varying control chart techniques, information, and roadmaps to ensure their control charts are operating efficiently and producing specification-confirming products. This is the essential text on the theories and applications behind statistical methods and control procedures. This eight-chapter reference breaks information down into digestible sections and covers topics including: ● An introduction to the basics as well as a background of control charts ● Widely used and newly researched attributes of control charts, including guidelines for implementation ● The process capability index for both normal and non-normal distribution via the sampling of multiple dependent states ● An overview of attribute control charts based on memory statistics ● The development of control charts using EQMA statistics For a solid understanding of control methodologies and the basics of quality assurance, Introduction to Statistical Process Control is a definitive reference designed to be read by practitioners and students alike. It is an essential textbook for those who want to explore quality control and systems design.
Book Synopsis The Biomedical Quality Auditor Handbook, Third Edition by : Heather Crawford
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 271 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 ASQs 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.
Book Synopsis The Certified Pharmaceutical GMP Professional Handbook, Second Edition by : Mark Allen Durivage
Download or read book The Certified Pharmaceutical GMP Professional Handbook, Second Edition written by Mark Allen Durivage and published by Quality Press. This book was released on 2016-05-26 with total page 386 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.
Book Synopsis Statistical Process Control by : G. Barrie Wetherill
Download or read book Statistical Process Control written by G. Barrie Wetherill and published by Springer. This book was released on 2013-08-02 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Statistical process control (SPC) is now recognized as having a very important role to play in modern industry. Our aim in this book has been to present SPC techniques in a simple and clear way, and also to present some of the underlying theory and properties of the techniques. This volume arises partly out of a revision of Wetherill (1977), and partly out of experience in teaching and implementing SPC at industrial sites, especially with ICI. It would have been impossible to come to our present understanding of this field without the joint efforts of industry and university. A number of features of this book are new: (1) The special emphasis on process industry problems, including one at-a-time data. (2) The discussion of between and within-group variation, and the effects of this on charting and on process capability analysis. (3) The derivation of the properties of the techniques has not been gathered together before. (4) The presentation of sampling by variables contains many new features. The techniques themselves are presented in a very simple way by using 'method summaries', and these could be a basis for training when SPC is implemented.
Book Synopsis Statistical Process Control for Managers, Second Edition by : Victor E. Sower
Download or read book Statistical Process Control for Managers, Second Edition written by Victor E. Sower and published by Business Expert Press. This book was released on 2017-09-21 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you have been frustrated by very technical statistical process control (SPC) training materials, then this is the book for you. This book focuses on how SPC works and why managers should consider using it in their operations. It provides you with a conceptual understanding of SPC so that appropriate decisions can be made about the benefits of incorporating SPC into the process management and quality improvement processes. Today there is little need to make the necessary calculations by hand, so the author utilizes Minitab and NWA Quality Analyst—two of the most popular statistical analysis software packages on the market. Links are provided to the home pages of these software packages where trial versions may be downloaded for evaluation and trial use. The book also addresses the question of why SPC should be considered for use, the process of implementing SPC, how to incorporate SPC into problem identification, problem solving, and the management and improvement of processes, products, and services.
Book Synopsis Handbook of Investigation and Effective CAPA Systems, Second Edition by : José Rodríguez-Pérez
Download or read book Handbook of Investigation and Effective CAPA Systems, Second Edition written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2016-04-04 with total page 214 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understanding and improving the CAPA system as a whole is the focal point of this book, the only of its kind dealing exclusively with this critical system within highly regulated industries. Features include: Information about the importance of the CAPA system within the quality system for the medical products regulated industry. Fully updated with current versions of regulations (U.S. FDA, EU, ISO 13485, and so on), and a new section covers the regulatory expectation of customer complaint investigations. Investigation and CAPA elements of the 2015 revision of the ISO 9001 standard. New coverage on the investigation plan and the new U.S. FDA quality metric guidance, as well as a section discussing the tight relationship between CAPAs and FMEA. A new chapter fully devoted to human errors and human factors, and their impact in the investigation and CAPA system. Discussion of a dozen of the most common pitfalls commonly encountered in the investigation and CAPA world of regulated companies. An example of an investigation and CAPA expert certification program being used for many companies. Forms and examples of the different elements (investigation report, root causes checklist, human error investigation, CAPA plan, and so on) covered in the book. Fully usable forms are also included in the companion CD in Microsoft Word format. While the first edition of this book was aimed solely at the FDA-regulated industry, the title of this second edition reflects the importance of the investigation/root cause analysis stage as the necessary preceding step of any effective corrective and preventive action system. Investigation and CAPA are concepts used in many sectors besides the FDA-regulated industry, such as: automotive, electronics, aerospace, telecommunications, process industry, and many more. This book will become an essential reference for those in these other industries.
