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Author :
Publisher :
ISBN 13 : 9781570205811
Total Pages : 395 pages
Book Rating : 4.2/5 (58 download)
Download or read book The Quality System Compendium written by and published by . This book was released on 2015 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 180 pages
Book Rating : 4.3/5 (121 download)
Download or read book EPA Water Program Information Systems Compendium written by and published by . This book was released on 1998 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Itay Abuhav
Publisher : CRC Press
ISBN 13 : 1351000772
Total Pages : 735 pages
Book Rating : 4.3/5 (51 download)
Download or read book ISO 13485:2016 written by Itay Abuhav and published by CRC Press. This book was released on 2018-05-11 with total page 735 pages. Available in PDF, EPUB and Kindle. Book excerpt: Summary: This book provides valuable, effective guidance for understanding, interpreting and implementing ISO 13485:2016 standard requirements. Despite its more than 800-page length, the author has specifically designed its contents to maximize usability for the reader with a table of contents identical to that of the ISO standard itself, which enables easy navigation and orientation. Pragmatic in style and down to earth in tone, this book draws real-life examples and case-studies from the author’s many years of experience in consulting to illustrate even the most complex of ISO 13485:2016 standard requirements and their implementation. Identifying relevant requirements and how they harmonize with quality management systems, developing processes for design and development, as well as product realization and validation are just a few of the issues covered in-depth by this publication. In addition, the author constantly reviews the distinctive characteristics and aspects of the medical device manufacturing industry, so that the reader can also appreciate the subject of this book in an everyday context. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. Uses examples and cases from real-life based on the author’s many years of experience in quality management. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier navigation and orientation for the reader. Emphasises guidance for ISO 13495:2016 standard requirements which are difficult to interpret and implement Constantly reviews the aspect of medical device industry characteristics and distinctive so the reader can reflect the content with its daily work.
Author : Ray Tricker
Publisher : Taylor & Francis
ISBN 13 : 1136378758
Total Pages : 608 pages
Book Rating : 4.1/5 (363 download)
Download or read book MDD Compliance Using Quality Management Techniques written by Ray Tricker and published by Taylor & Francis. This book was released on 2012-04-27 with total page 608 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Medical Devices Directive (MDD) is an all-encompassing document legislating for the manufacture of any medical device or material used either temporarily or permanently on or in the human body. To achieve its main objectives the MDD requires the manufacturer of all products covered by the Directive to possess a fully auditable Quality Management System consisting of Quality Policies, Quality Procedures and Work Instructions, based on the ISO 9000 standard. The book is based on the sound principles of ISO 9000 and will guide to the reader, if required, to eventually set up an ISO 9000 fully compliant system. MDD-Compliance using Quality Management Techniques consists of the following: * A brief guide to the Medical Devices Directive - explaining the main requirements of the directive, translating legal "Eurospeak" into everyday language * An overview of ISO 9000 and how the MDD links in with these international requirements. * A Quality Manual - will provide a template for a complete Quality Management System that can be used by any product being produced under the requirements of the MDD * CD ROM containing a software copy of the Quality Manual * A User manual consisting of clear instructions and flow charts on how to set up and use the Quality Management System described in the Quality Manual
Author : Howard S. Gitlow
Publisher : Irwin/McGraw-Hill
ISBN 13 : 9780073662633
Total Pages : 797 pages
Book Rating : 4.6/5 (626 download)
Download or read book Quality Management written by Howard S. Gitlow and published by Irwin/McGraw-Hill. This book was released on 2005 with total page 797 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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Publisher :
ISBN 13 :
Total Pages : 134 pages
Book Rating : 4.3/5 (121 download)
Download or read book Office of Water Environmental and Program Information Systems Compendium, FY 1990 written by and published by . This book was released on 1990 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Environmental Protection Agency
Publisher :
ISBN 13 :
Total Pages : 848 pages
Book Rating : 4.:/5 (319 download)
Download or read book EPA National Publications Catalog written by United States. Environmental Protection Agency and published by . This book was released on 1998 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
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ISBN 13 :
Total Pages : 856 pages
Book Rating : 4.E/5 ( download)
Download or read book EPA 200-B. written by and published by . This book was released on 1998 with total page 856 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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Publisher :
ISBN 13 :
Total Pages : 356 pages
Book Rating : 4.3/5 (121 download)
Download or read book Federal Register written by and published by . This book was released on 2012-05 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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ISBN 13 :
Total Pages : 430 pages
Book Rating : 4.0/5 ( download)
Download or read book ISO 9000 Quality Management written by and published by . This book was released on 2001 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : HHS Policy Information Center (U.S.)
Publisher :
ISBN 13 :
Total Pages : 602 pages
Book Rating : 4.:/5 (3 download)
Download or read book Compendium of HHS Evaluations and Relevant Other Studies written by HHS Policy Information Center (U.S.) and published by . This book was released on 1990 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : International Organization for Standardization
Publisher :
ISBN 13 :
Total Pages : 796 pages
Book Rating : 4.:/5 (319 download)
Download or read book Catalogue written by International Organization for Standardization and published by . This book was released on 2003 with total page 796 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Steven M. Spivak
Publisher : CRC Press
ISBN 13 : 1351829785
Total Pages : 344 pages
Book Rating : 4.3/5 (518 download)
Download or read book Standardization Essentials written by Steven M. Spivak and published by CRC Press. This book was released on 2018-10-08 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ready reference surveys the discipline of standards and standardization, defining common terms, clarifying descriptions, describing how standards could be used to restrain trade, and explaining how international trade is stimulated by the due process provisions of standards writing organizations. Containing real-world examples provided by experienced standards professionals, Standardization Essentials is a vital, forward-looking reference for mechanical, civil, electrical and electronics, materials, chemical, mineral, cost, quality, reliability, industrial, developmental, safety, forensic, and consulting engineers; standards managers; architects; project managers; upper-level undergraduate, graduate, and continuing education students in these disciplines. Crystallizes the essential role that standards play in strategic standardization management, purchasing, contractual agreements, and international trade! Covering costs, benefits, limitations, uses, and abuses of standardization programs, Standardization Essentials Considers whether standards build or bar trade and the use of international standards to leverage world markets Presents a case study of conformity assessment related to international technical trade barriers Focuses on consumer safety standards for automobile tires and other products Addresses implementation of ISO 9000 and ISO 14000 management system standards in industry Highlights voluntary (nongovernmental) and mandatory (governmental) standards and regulations developed by a variety of organizations Reveals competition, incongruities, and harmonization among national and international standards
Author : World Health Organization
Publisher : World Health Organization
ISBN 13 : 9241547081
Total Pages : 414 pages
Book Rating : 4.2/5 (415 download)
Download or read book Quality Assurance of Pharmaceuticals written by World Health Organization and published by World Health Organization. This book was released on 2007 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance of pharmaceutical products is a continuing concern of WHO. Despite efforts made around the world to ensure a supply of quality and effective medicines, substandard, spurious and counterfeit products still compromise health care delivery in many countries. To respond to the global need for adequate quality assurance of pharmaceuticals, WHO's Expert Committee on Specifications for Pharmaceutical Preparations has over the years made numerous recommendations to establish standards and guidelines and to promote the effective functioning of national regulatory and control systems and the implementation of internationally agreed standards by trained personnel. Many of the relevant documents endorsed by the Committee are reproduced in this volume providing guidance covering all aspects of good manufacturing practices (GMP). Important texts on inspection are also included. Most of the material has been published separately in the Expert Committee's reports. This compendium brings it together to make it more accessible and of greater practical value to those working in faculties of pharmacy, in medicines regulation and control and in the pharmaceutical industry. This is the second updated edition of the compendium and includes texts published in 2005 and 2006 in the WHO Technical Report Series.
Author : Ratikanta Maiti
Publisher : Springer
ISBN 13 : 9811009953
Total Pages : 285 pages
Book Rating : 4.8/5 (11 download)
Download or read book Bioresource and Stress Management written by Ratikanta Maiti and published by Springer. This book was released on 2016-07-20 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a compilation of recent global measures to conserve bio-resources and manage biotic and abiotic stresses. It highlights emerging issues related to agriculture, abiotic and biotic stress factors, ethnic knowledge, climate change and global warming, as well as natural resources and their sustainable management. It also focuses on the consolidated efforts of scientists and academics engaged in addressing a number of issues related to resource management and combating stresses in order to protect the Earth. Crop production and productivity have been significantly improved, however, there have been no corresponding practical advances in sustainable agriculture.This book offers a wide range of affordable approaches to managing bio-resources with a focus on sustainability. Lastly, it describes research highlights and future areas of research.
Author : WHO Expert Committee on Specifications for Pharmaceutical Preparations
Publisher : World Health Organization
ISBN 13 : 9241209860
Total Pages : 401 pages
Book Rating : 4.2/5 (412 download)
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by WHO Expert Committee on Specifications for Pharmaceutical Preparations and published by World Health Organization. This book was released on 2014 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances. The International Pharmacopoeia - updating mechanism for the section on radiopharmaceuticals; WHO good manufacturing practices for pharmaceutical products: main principles; Model quality assurance system for procurement agencies; Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection; Guidelines on submission of documentation for prequalification of finished pharmaceutical products approved by stringent regulatory authorities; and Guidelines on submission of documentation for a multisource (generic) finished pharmaceutical product: quality part.
Author : Graham Ogg
Publisher : CRC Press
ISBN 13 : 104006163X
Total Pages : 229 pages
Book Rating : 4.0/5 (4 download)
Download or read book A Practical Guide to Quality Management in Clinical Trial Research written by Graham Ogg and published by CRC Press. This book was released on 2005-11-01 with total page 229 pages. Available in PDF, EPUB and Kindle. Book excerpt: Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a co
