The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel

Publisher: ASQ Quality Press

ISBN: 0873897404

Category: Medical

Page: 304

View: 4496

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How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

The Certified Pharmaceutical GMP Professional Handbook, Second Edition

Author: Mark Allen Durivage

Publisher: ASQ Quality Press

ISBN: 0873899334

Category: Business & Economics

Page: 516

View: 6703

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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.

Statistical Process Control for the FDA-Regulated Industry

Author: Manuel E. Pena-Rodriguez

Publisher: ASQ Quality Press

ISBN: 0873898524

Category: Business & Economics

Page: 204

View: 9931

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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.

Human Error Reduction in Manufacturing

Author: José Rodríguez-Pérez

Publisher: ASQ Quality Press

ISBN: 0873899733

Category: Business & Economics

Page: 268

View: 9303

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For many years, we considered human errors or mistakes as the cause of mishaps or problems. In the manufacturing industries, human error, under whatever label (procedures not followed, lack of attention, or simply error), was the conclusion of any quality problem investigation. The way we look at the human side of problems has evolved during the past few decades. Now we see human errors as the symptoms of deeper causes. In other words, human errors are consequences, not causes. The basic objective of this book is to provide readers with useful information on theories, methods, and specific techniques that can be applied to control human failure. It is a book of ideas, concepts, and examples from the manufacturing sector. It presents a comprehensive overview of the subject, focusing on the practical application of the subject, specifically on the human side of quality and manufacturing errors. In other words, the primary focus of this book is human failure, including its identification, its causes, and how it can be reasonably controlled or prevented in the manufacturing industry setting. In addition to including a detailed discussion of human error (the inadvertent or involuntary component of human failure), a chapter is devoted to analysis and discussion related to voluntary (intentional) noncompliance. Written in a direct style, using simple “industry” language with abundant applied examples and practical references, this book’s insights on human failure reduction will improve individual, organizational, and social well-being.

Books in Print

Author: N.A

Publisher: N.A

ISBN: N.A

Category: American literature

Page: N.A

View: 4631

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Books in print is the major source of information on books currently published and in print in the United States. The database provides the record of forthcoming books, books in-print, and books out-of-print.

Qualitätssicherung für Dummies

Author: Larry Webber,Michael Wallace

Publisher: John Wiley & Sons

ISBN: 3527817689

Category: Business & Economics

Page: 260

View: 7804

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"Qualitätssicherung für Dummies" führt Sie in die Grundlagen des Qualitätsmanagements ein und zeigt, wie Sie durch strukturiertes, systematisches Vorgehen die operative Umsetzung des Qualitätsmanagements unterstützen. Die Autoren Larry Webber und Michael Wallace definieren zunächst den Begriff "Qualität", erklären die Bedeutung von Qualitätsstandards und wie sich diese auf die Produkte und Strategien in einem Unternehmen auswirken. Anhand von vielen Methoden und Instrumenten wie Six Sigma, Kanban, Kaizen, Lean, 5S und der Meinung der Kunden erfahren Sie, wie Sie Prozessqualität messen können und bei der Umsetzung dieses Systems die Mitarbeiter nicht außen vor lassen.

Unsere Gene

eine Gebrauchsanleitung für ein besseres Leben

Author: Terry Burnham,Jay Phelan

Publisher: N.A

ISBN: 9783870245276

Category: Science

Page: 316

View: 676

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Hollywood in Cannes

die Geschichte einer Hassliebe, 1939-2008

Author: Christian Jungen

Publisher: N.A

ISBN: N.A

Category: Blockbusters (Motion pictures)

Page: 383

View: 5376

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