Good Laboratory Practice Regulations Management Briefings PDF Download

Author: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 60

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0824745647
Category : Medical
Languages : en
Pages : 256

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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 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.

Author: USA. Food and Drug Administration
Publisher:
ISBN:
Category :
Languages : en
Pages : 53

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Book Description

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: United States. Food and Drug Administration
Publisher:
ISBN:
Category : Laboratories
Languages : en
Pages : 106

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Book Description

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 0849375843
Category : Medical
Languages : en
Pages : 306

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Book Description
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

Author: Jürg P. Seiler
Publisher: Springer Science & Business Media
ISBN: 3642868789
Category : Medical
Languages : en
Pages : 404

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Book Description
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.

Author: Milton A. Anderson
Publisher: Informa Healthcare
ISBN: 9781574911060
Category : Business & Economics
Languages : en
Pages : 424

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Book Description
Designed to enable readers to plan and execute their own audits, this comprehensive guide presents both discussions and practical applications related to establishing a GLP QA unit and performing effective GLP audits. The first section provides the foundation of information needed for designing and initiating a Good Laboratory Practice quality assurance program. Section II contains ready-to-use audit checklists and regulatory references that are in accordance with the most recent regulations. Section III illustrates with examples the document requirements of the Quality Assurance Unit and provides a clear understanding of its function. Section IV comprises the full texts of the relevant standards and regulations along with the Principles of Good Laboratory Practice.

Author: Sandy Weinberg
Publisher: CRC Press
ISBN: 9781135552503
Category : Medical
Languages : en
Pages : 264

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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 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.

Author: Food and Drug Administration
Publisher: CRC Press
ISBN: 1135489661
Category : Medical
Languages : en
Pages : 54

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Book Description
The Compact Regs series provides full-text, pocket-sized format (3 3/4 inch x 5 1/2 inch) verbatim reproductions of key US FDA regulations. The texts are complete and have not been altered in any manner from the original sources. They are the perfect low-cost tools for: employees as part of documented GMP training programs, for suppliers/vendors so