Implementing a Good Laboratory Practice Training Program for Regulatory Personnel

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Publisher :
ISBN 13 :
Total Pages : 566 pages
Book Rating : 4.:/5 (817 download)

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Book Synopsis Implementing a Good Laboratory Practice Training Program for Regulatory Personnel by : Julia Solarczyk Donnelly

Download or read book Implementing a Good Laboratory Practice Training Program for Regulatory Personnel written by Julia Solarczyk Donnelly and published by . This book was released on 2006 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Good Laboratory Practice Regulations, Revised and Expanded

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Publisher : CRC Press
ISBN 13 : 0203911083
Total Pages : 249 pages
Book Rating : 4.2/5 (39 download)

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Book Synopsis Good Laboratory Practice Regulations, Revised and Expanded by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations, Revised and Expanded written by Sandy Weinberg and published by CRC Press. This book was released on 2002-11-06 with total page 249 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Good Laboratory Practice Regulations, Third Edition, Revised and Expanded

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Publisher : CRC Press
ISBN 13 : 0824745647
Total Pages : 256 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations, Third Edition, Revised and Expanded written by Sandy Weinberg and published by CRC Press. This book was released on 2002-11-06 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

Good Laboratory Practice

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Publisher : Springer Science & Business Media
ISBN 13 : 3642868789
Total Pages : 404 pages
Book Rating : 4.6/5 (428 download)

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Book Synopsis Good Laboratory Practice by : Jürg P. Seiler

Download or read book Good Laboratory Practice written by Jürg P. Seiler and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: After more than twenty years of use Good Laboratory Practice, or GLP, has attained a secure place in the world of testing chemicals and other "test items" with regard to their safety for humans and the environment. Gone are the days when the GLP regulations were hotly debated amongst scientists in academia and industry and were accused of stifling flexibility in, imaginative approaches to, and science-based conduct of, all kinds of studies concerned with toxic effects and other parameters important for the evaluation and assessment of products submitted for registration and permission to market. The GLP regulations have developed from rules on how to exactly document the planning, conduct and reporting of toxicity studies to a quality system for the management of a multitude of study types, from the simple determination of a physical/chemical parameter to the most complex field tests or ecotoxicology studies. At the same time the term "Good Laboratory Practice" has become somewhat of a slogan with the aim to characterise any reliably conducted laboratory work.

Good Laboratory Practice Regulations

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Publisher : CRC Press
ISBN 13 :
Total Pages : 320 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Good Laboratory Practice Regulations by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations written by Sandy Weinberg and published by CRC Press. This book was released on 1995 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

GLP Essentials

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Publisher : CRC Press
ISBN 13 : 9781574911381
Total Pages : 67 pages
Book Rating : 4.9/5 (113 download)

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Book Synopsis GLP Essentials by : Milton A. Anderson

Download or read book GLP Essentials written by Milton A. Anderson and published by CRC Press. This book was released on 2002 with total page 67 pages. Available in PDF, EPUB and Kindle. Book excerpt: Concise and easy to follow, this book explains the implementation of Good Laboratory Practices (GLPs). The second edition of a standard reference, GLP Essentials identifies and describes the required elements of managing a scientific study including its planning, performance, reporting, and monitoring. The author includes a brief, informative discussion of the historical development of GLPs and the rationale for establishing these requirements in the rapidly expanding scientific research and regulatory environment. Written especially for readers involved in ensuring the integrity of their scientific documentation, this book is useful for individual and group training programs.

Good Automated Laboratory Practices

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Publisher : DIANE Publishing
ISBN 13 : 1428906126
Total Pages : 167 pages
Book Rating : 4.4/5 (289 download)

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Book Synopsis Good Automated Laboratory Practices by :

Download or read book Good Automated Laboratory Practices written by and published by DIANE Publishing. This book was released on 1990 with total page 167 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Good Laboratory Practice for Nonclinical Studies

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Publisher : CRC Press
ISBN 13 : 1000789594
Total Pages : 179 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Good Laboratory Practice for Nonclinical Studies by : Graham P. Bunn

Download or read book Good Laboratory Practice for Nonclinical Studies written by Graham P. Bunn and published by CRC Press. This book was released on 2022-12-13 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GLP regulations have been enacted since 1978 and are currently under a proposed FDA amendment to revise terminology and accommodate other changes relating to advances in technology related to the industry. This book provides a unique opportunity to access interpretation of the 21CFR58 regulatory requirements from leading industry experts with a vast knowledge and expertise in their fields. The approach used takes the regulations, provides interpretations and references to examples and regulatory actions. Data integrity and the use of electronic systems in compliance with 21CFR11 Electronic Records: Electronic Signatures are also discussed. • Unique volume covering FDA inspections of GLP facilities • Provides a detailed interpretation of GLP Regulations • Presents the latest on electronic data management in GLP • Describes GLP and computer systems validation • Can be referenced repeatedly in supporting daily hands on implementation of the CFR requirements

Good Laboratory Practice Regulations, Fourth Edition

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Publisher : CRC Press
ISBN 13 : 9780849375835
Total Pages : 0 pages
Book Rating : 4.3/5 (758 download)

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Book Synopsis Good Laboratory Practice Regulations, Fourth Edition by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations, Fourth Edition written by Sandy Weinberg and published by CRC Press. This book was released on 2007-01-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresses every critical aspect of Good Laboratory Practice (GLP) regulations and demonstrates effective strategies for implementation in a variety of laboratory settings. This updated and expanded classic text contains new information about applying 21 CFR Part 11 to the laboratory environment, GLP documentation systems, laboratory risk analysis, system validation and inspection, process analytical technologies, and cost control for the prevention of pitfalls and the assurance of compliance in numerous research environments. Providing insights for the application of GLP regulations and emphasizing the latest regulatory developments, this reference discusses the implementation of PAT and emphasizes the importance of electronic audit trails and data controls as laboratories rely more on automated procedures...gives clear rules for the acceptance of electronic signatures, archiving of data in formats accessible by electronic recovery and human retrieval, and the security of electronic documents...and details the FDA’s GLP inspection program.

Good Laboratory Practice Regulations

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Publisher : CRC Press
ISBN 13 : 0849375843
Total Pages : 306 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Good Laboratory Practice Regulations by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations written by Sandy Weinberg and published by CRC Press. This book was released on 2007-01-19 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent changes in the interpretation and enforcement of 21 CFR Part 11 have shifted the focus of Good Laboratory Practice (GLP) regulations to concentrate on the acceptance of electronic signatures, the archiving of data, the security of electronic documents, and the automation of laboratory procedures. This all-encompassing Fourth Edition addresse

Good Laboratory Practice Regulations, Third Edition, Revised and Expanded

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Author :
Publisher : CRC Press
ISBN 13 : 9781135552480
Total Pages : 264 pages
Book Rating : 4.5/5 (524 download)

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Book Synopsis Good Laboratory Practice Regulations, Third Edition, Revised and Expanded by : Sandy Weinberg

Download or read book Good Laboratory Practice Regulations, Third Edition, Revised and Expanded written by Sandy Weinberg and published by CRC Press. This book was released on 2002-11-06 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 guidelines for the management of efficient and effective research environment. A guide to the current standards and requirements of good laboratory management, the book examines essential theoretical principles for anticipating new and emerging interpretations of GLP in a variety of laboratory settings.

Good Laboratory Practice Regulations Management Briefings

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Publisher :
ISBN 13 :
Total Pages : 60 pages
Book Rating : 4.:/5 (31 download)

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Book Synopsis Good Laboratory Practice Regulations Management Briefings by : United States. Food and Drug Administration

Download or read book Good Laboratory Practice Regulations Management Briefings written by United States. Food and Drug Administration and published by . This book was released on 1979 with total page 60 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Good Laboratory Practice Regulations

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Author :
Publisher : Marcel Dekker
ISBN 13 :
Total Pages : 248 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Good Laboratory Practice Regulations by : Allen F. Hirsch

Download or read book Good Laboratory Practice Regulations written by Allen F. Hirsch and published by Marcel Dekker. This book was released on 1989 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Good Laboratory Practice in the Testing of Chemicals

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Publisher :
ISBN 13 :
Total Pages : 84 pages
Book Rating : 4.:/5 (41 download)

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Book Synopsis Good Laboratory Practice in the Testing of Chemicals by : Organisation for Economic Co-operation and Development. Group of Experts on Good Laboratory Practice

Download or read book Good Laboratory Practice in the Testing of Chemicals written by Organisation for Economic Co-operation and Development. Group of Experts on Good Laboratory Practice and published by . This book was released on 1982 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt:

OECD Principles of Corporate Governance

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Publisher : OECD Publishing
ISBN 13 : 9264173706
Total Pages : 42 pages
Book Rating : 4.2/5 (641 download)

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Book Synopsis OECD Principles of Corporate Governance by : OECD

Download or read book OECD Principles of Corporate Governance written by OECD and published by OECD Publishing. This book was released on 1999-10-06 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: These principles of corporate governance, endorsed by the OECD Council at Ministerial level in 1999, provide guidelines and standards to insure inclusion, accountability and abilit to attract capital.

Handbook

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Publisher :
ISBN 13 :
Total Pages : 256 pages
Book Rating : 4.E/5 ( download)

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Book Synopsis Handbook by :

Download or read book Handbook written by and published by . This book was released on 2001 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Good Laboratory Practice Training Manual

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Author :
Publisher : World Health Organization
ISBN 13 : 924154757X
Total Pages : 265 pages
Book Rating : 4.2/5 (415 download)

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Book Synopsis Good Laboratory Practice Training Manual by : World Health Organization

Download or read book Good Laboratory Practice Training Manual written by World Health Organization and published by World Health Organization. This book was released on 2010-02-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual is designed to be used by the trainee at Special Program for Research and Training in Tropical Diseases and Good Laboratory Practice training workshops. It contains an introduction which highlights the history of the OECD principles of GLP, and the fundamental points. Included is training on the resources required (personnel and facilities); preparation of the protocol and standard operating procedures (SOPs); characterization of the test item (its storage, use, quality control, test system); documentation (reporting, deviations from the protocol, indexing, archiving, retrieval); and quality assurance (validity of results must be ensured through all phases of a study). The material is presented in a clear, lively and informative way. Also included are several practical and interesting workshops on how to prepare, review and improve protocols and standard operating procedures, based on actual case studies. Finally there is a self-assessment questionnaire-so the trainee can recognize how much he/she has learned and what issues need clarification, if any.