GMP/ISO Quality Audit Manual for Healthcare Manufacturers and Their Suppliers, (Volume 2 - Regulations, Standards, and Guidelines) PDF Download
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Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 453
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Book Description
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author: Leonard Steinborn
Publisher: CRC Press
ISBN: 0203026659
Category : Medical
Languages : en
Pages : 453
Get Book Here
Book Description
This well-known QA manual has been updated to provide the guidance readers need to assess their compliance with standard regulations. This Volume 2 of a three-part package contains the full text on: * FDA regulations* EC and IPEC guidelines* ISO/BSI standards referenced in the checklists furnished in volume 1Easy-to-read and organized to provide fa
Author: Kate McCormick
Publisher: Butterworth-Heinemann
ISBN: 9780750651134
Category : Business & Economics
Languages : en
Pages : 296
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Book Description
The Pharmaceutical Engineering Series is a comprehensive reference for the pharmaceutical professional covering all aspects from quality, documentation and validation through manufacturing processes to facility design and management. In 'Quality', Dr Kate McCormick provides the reader with comprehensive coverage of this vital subject, including the quality life cycle, management and cost of quality, GMP, auditing and inspections. This book with the others in the series will become a unique source of reference and educational material for the readership. Case studies and examples make the book of direct practical relevance to the professional in the pharmaceutical industry Find the answers you are looking for quickly and easily with clear indexing and referencing Reference to international standards and practice mean this book will be useful wherever you are working
Author: Raymond Kimber
Publisher: CRC Press
ISBN: 9780824793562
Category : Technology & Engineering
Languages : en
Pages : 848
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Book Description
"Affords an advantageous understanding of contemporary management and total quality systems without excessive employment of advanced mathematics--directing managers in the implementation of the basic quality framework that will lead to improved production and increased profits through sound quality practices. Provides practical applications in a wide variety of industrial, financial, service, and administrative systems and shows how to prepare for quality audits, product meetings, and production discussions. Features 21 new chapters."
Author: H.W. Chung
Publisher: Routledge
ISBN: 1135804397
Category : Architecture
Languages : en
Pages : 262
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Book Description
The ISO 9000 family of quality standards has been adopted world-wide as a framework for building better relationships between suppliers and customers. Originally a manufacturing-industry concern, quality is now acknowledged to be a key issue for the construction sector whose clients increasingly demand quality certification. This book explains the concepts and practice of quality assurance and management in construction. Clearly written and well illustrated, with plenty of sample quality system documents and other pro-forma, this book will make the daunting task of developing, implementing and managing a quality system a great deal easier for contractors. This is practical guide for building and construction contractors and sub-contractors, project managers and other construction professionals. Also for undergraduate and postgraduate students of building, construction management and project management.
Author: Andrew Bolton
Publisher: Springer Science & Business Media
ISBN: 1461521890
Category : Business & Economics
Languages : en
Pages : 204
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Book Description
In recent years there has been growing pressure for consistent product quality, and a need for companies to demonstrate sound quality management practices in order to meet 'Due Diligence' requirements of both legislation and the quality assurance practices of customers. It has become accepted that operating to the requirements of the international standard for quality management - BS EN ISO 900- goes a long way towards meeting these needs. The objective of this book is to explain the requirements of the standard, to offer advice about achieving those requirements and to indicate what the assessors will look for at assessment time. It is important that certification to the standard is sought to support achievement of company objectives and not the reverse, and of course the standard can apply to organizations and services, just as much as to companies. Thus the word' company' in the text should be treated accordingly. lllustrative material has been presented under the logo of a fictiti ous company 'Quality Food Services' - in this context QFS does not bear any relationship whatsoever to any identically or similarly named business that may exist. Readers will find it helpful to read the book with a copy of the standard to hand, and are strongly encouraged to read the complete text before taking any steps to prepare for certification to the standard.
Author: Michael B. Weinstein
Publisher: Routledge
ISBN: 1351407716
Category : Business & Economics
Languages : en
Pages : 228
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Book Description
Total Quality Management (TQM) is a business philosophy that yields customer satisfaction and continuous process improvement. This new reference and workbook embraces the TQM revolution and explains to readers how TQM principles are applied to safety and health programs. The text also focuses on the ISO-9000 Quality Program, Voluntary Protection Program, and Process Safety Management. For each of these topics, the key principles are identified and described, and the quality principles are adapted to safety.
Author: G. M. S. de Silva
Publisher: Routledge
ISBN: 1136427198
Category : Business & Economics
Languages : en
Pages : 198
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Book Description
Traceable calibration of test and measurement equipment is a requirement of the ISO 9000 series of standards. Basic Metrology for ISO 9000 Certification provides essential information for the growing number of firms registered for ISO 9000. Dr. G.M.S. de Silva who has a lifetime of experience in metrology and quality management fields condenses that knowledge in this valuable and practical workbook. The book provides a basic understanding of the principles of measurement and calibration of measuring instruments falling into the following fields; Length,Angle, Mass, Pressure, Force, Temperature and AC/DC Electrical quantities. Basic concepts and definitions, ISO 9001 requirements and uncertainty determinations are also included.
Author: Matthias Jarke
Publisher: Springer Science & Business Media
ISBN: 3662051532
Category : Computers
Languages : en
Pages : 328
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Book Description
This book presents the first comparative review of the state of the art and the best current practices of data warehouses. It covers source and data integration, multidimensional aggregation, query optimization, metadata management, quality assessment, and design optimization. A conceptual framework is presented by which the architecture and quality of a data warehouse can be assessed and improved using enriched metadata management combined with advanced techniques from databases, business modeling, and artificial intelligence.
Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 404
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Book Description
Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author:
Publisher:
ISBN:
Category : Administrative law
Languages : en
Pages : 372
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Book Description
The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
