Author:
Publisher: DIANE Publishing
ISBN: 1428906126
Category : Environmental laboratories
Languages : en
Pages : 167

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 9781566700252
Category : Science
Languages : en
Pages : 470

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Book Description
The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0203911083
Category : Medical
Languages : en
Pages : 249

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Book Description
Fully updated and revised to include the latest information since publication of the first edition in 1989, the Second Edition of this highly praised reference covers all aspects of the Food and Drug Administration's (FDA) Good Laboratory Practice (GLP) regulations and techniques for implementation. The book details specific standards and general g

Author: Donald C. Singer
Publisher: Quality Press
ISBN: 0873891090
Category : Business & Economics
Languages : en
Pages : 401

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Book Description
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation

Author: United States Environmental Protection Agency (EPA)
Publisher: Createspace Independent Publishing Platform
ISBN: 9781722723507
Category :
Languages : en
Pages : 34

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Book Description
Draft Automated Laboratory Standards Evaluation Of The Standards And Procedures Used In Automated Clinical Laboratories

Author: International Validation Forum
Publisher: CRC Press
ISBN: 1040280684
Category : Science
Languages : en
Pages : 1114

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Book Description
"Offers an overview of validation and the current regulatory climate and provides a compendium of the regulations, guidance documents, issues, compliance tools, terminology, and literature involved in computer systems validation. Thoroughly examines regulations issued by the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, and the European Union. Furnishes case studies of real-world situations."

Author: International Validation Forum
Publisher: CRC Press
ISBN: 9780824797461
Category : Science
Languages : en
Pages : 860

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Book Description
This biannual offers detailed coverage of the regulations, requirements, and techniques for the validation of processes and systems used in regulated international industries. It addresses significant requirements for pharmaceutical, medical device, and biologic companies as well as environmental laboratories. It examines Good Manufacturing Principles (GMPs), Good Clinical Practices (GCPs), Good Laboratory Practices (GLPs), Good Automated Library Practices (GALPs), and others, and elucidates up-to-the-minute industry changes and international concerns.

Author:
Publisher:
ISBN:
Category : Environmental protection
Languages : en
Pages : 784

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN:
Category : Biological laboratories
Languages : en
Pages : 320

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Book Description
This work covers all aspects of the Food and Drug Administration's Good Laboratory Practice relgulations and techniques for implementation. This edition includes general knowledge on computer system validation, details on implementing GIPs in an automated laboratory, a forecast of the flexibility and effectiveness of GLPs in the changing laboratory environment, and a contemporary bibliography with new references.

Author: Carla H. Dempsey
Publisher: CRC Press
ISBN: 1000157741
Category : Law
Languages : en
Pages : 258

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Book Description
This book provides descriptions of current laboratory accreditation schemes and explains why these schemes fall short of assuring data purchasers that the data produced from accredited laboratories are always quality products. The book then presents a system for laboratory accreditation in conjunction with data certification that assures data purchasers their data are useful for the purposes for which they are intended. Simple quality assurance and quality control techniques, in addition to concepts of total quality management, are described and then applied to the environmental laboratory industry. This "System For Success" was developed from real problems and real solutions within the industry and represents an integration of proven techniques that offer a better way to ensure quality laboratory data is obtained. Laboratory Accreditation: A Workable Solution is a must for government officials, environmental professionals, independent environmental laboratories, hazardous waste disposal industries, chemical manufacturers, QA professionals, and testing laboratories.