The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author:
Publisher: Asq Press
ISBN:
Format: PDF, Mobi
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This book provides essential information regarding the new FDA regulation for medical devices and international quality system requirements (ISO 9001 and ISO/DIS 13485:1996). Icons quickly establish the differences and relationship between FDA regulation, the ISO 9001 standard, FDA guidance, and the Global Harmonization Task Force (GHTF) guidance. In addition, the end of each subsection includes blank pages for your notes. This book allows manufacturers to establish a single quality system that satisfies world requirements.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

Author: Amiram Daniel
Publisher: ASQ Quality Press
ISBN: 0873897404
Format: PDF, ePub, Docs
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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 FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Author: José Rodríguez-Pérez
Publisher: ASQ Quality Press
ISBN: 0873898699
Format: PDF, Kindle
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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.

Medical Device Regulatory Practices

Author: Val Theisz
Publisher: CRC Press
ISBN: 9814669113
Format: PDF, ePub
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This book is intended to serve as a reference for professionals in the medical device industry, particularly those seeking to learn from practical examples and case studies. Medical devices, like pharmaceuticals, are highly regulated, and the bar is raised constantly as patients and consumers expect the best-quality healthcare and safe and effective medical technologies. Obtaining marketing authorization is the first major hurdle that med techs need to overcome in their pursuit of commercial success. Most books on regulatory affairs present regulations in each jurisdiction separately: European Union, USA, Australia, Canada, and Japan. This book proposes practical solutions for a coherent, one-size-fits-all (or most) set of systems and processes in compliance with regulations in all key markets, throughout the life cycle of a medical device. It also contains key information about international harmonization efforts and recent regulatory trends in emerging markets; important terminology needed to understand the regulators’ language; and examples, case studies, and practical recommendations that bridge the gap between regulatory theory and practice.

The Certified Pharmaceutical GMP Professional Handbook Second Edition

Author: Mark Allen Durivage
Publisher: ASQ Quality Press
ISBN: 0873899334
Format: PDF, ePub
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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.

The Modern Rules of Order

Author: Donald A. Tortorice
Publisher: American Bar Association
ISBN: 9781590317921
Format: PDF, Docs
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This new edition of an ABA best-seller will provide anyone who conducts meetings with an easy framework for efficiency and fairness. With a system that is easy to implement, this book is organized in an intuitive fashion to make it easy to refer to for guidance during a meeting. The framework is perfect for any organization looking to adapt them as a starting point for their own customized bylaws. The book is fully indexed, and contains charts helpful for handling tricky situations at a glance.

The Certified HACCP Auditor Handbook Third Edition

Author: ASQ's Food, Drug, and Cosmetic Division
Publisher: ASQ Quality Press
ISBN: 0873898680
Format: PDF, Kindle
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This handbook is intended to serve as a baseline of hazard analysis critical control point (HACCP) knowledge for quality auditors. HACCP is more than just failure mode and effect analysis (FMEA) for food: it is a product safety management system that evolved and matured in the commercial food processing industry allowing food processors to take a proactive approach to prevent foodborne diseases. Both the FDA and the USDA have embraced HACCP as the most effective method to ensure farm-to-table food safety in the United States. This handbook also assists the certification candidate preparing for the ASQ Certified HACCP Auditor (CHA) examination. It includes chapters covering the HACCP audit, the HACCP auditor, and quality assurance analytical tools.

The Lean Six Sigma Black Belt Handbook

Author: Frank Voehl
Publisher: CRC Press
ISBN: 146655469X
Format: PDF, Kindle
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Although Lean and Six Sigma appear to be quite different, when used together they have shown to deliver unprecedented improvements to quality and profitability. The Lean Six Sigma Black Belt Handbook: Tools and Methods for Process Acceleration explains how to integrate these seemingly dissimilar approaches to increase production speed while decreasing variations and costs in your organization. Presenting problem-solving tools you can use to immediately determine the sources of the problems in your organization, the book is based on a recent survey that analyzed Six Sigma tools to determine which are the most beneficial. Although it focuses on the most commonly used tools, it also includes coverage of those used a minimum of two times on every five Six Sigma projects. Filled with diagrams of the tools you’ll need, the book supplies a comprehensive framework to help you for organize and process the vast amount of information currently available about Lean, quality management, and continuous improvement process applications. It begins with an overview of Six Sigma, followed by little-known tips for using Lean Six Sigma (LSS) effectively. It examines the LSS quality system, its supporting organization, and the different roles involved. Identifying the theories required to support a contemporary Lean system, the book describes the new skills and technologies that you need to master to be certified at the Lean Six Sigma Black Belt (LSSBB) level. It also covers the advanced non-statistical and statistical tools that are new to the LSSBB body of knowledge. Presenting time-tested insights of a distinguished group of authors, the book provides the understanding required to select the solutions that best fit your organization's aim and culture. It also includes exercises, worksheets, and templates you can easily customize to create your own handbook for continuous process improvement. Designed to make the methodologies you choose easy to follow, the book will help Black Belts and Senseis better engage their employees, as well as provide an integrated and visual process management structure for reporting and sustaining continuous improvement breakthroughs and initiatives.