OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Establishment and Control of Archives that Operate in Compliance with the Principles of GLP

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Establishment and Control of Archives that Operate in Compliance with the Principles of GLP PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264084991
Category :
Languages : en
Pages : 24

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Book Description
This document provides guidance concerning the establishment and control of archives compliant with the principles of Good Laboratory Practice, and is intended for use by test facilities, contract archives and quality assurance units and comliance authorities.

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Establishment and Control of Archives that Operate in Compliance with the Principles of GLP

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Establishment and Control of Archives that Operate in Compliance with the Principles of GLP PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264084991
Category :
Languages : en
Pages : 24

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Book Description
This document provides guidance concerning the establishment and control of archives compliant with the principles of Good Laboratory Practice, and is intended for use by test facilities, contract archives and quality assurance units and comliance authorities.

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Guidance on the GLP Requirements for Peer Review of Histopathology

OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Guidance on the GLP Requirements for Peer Review of Histopathology PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264228306
Category :
Languages : en
Pages : 11

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Book Description
This document provides guidance to pathologists, test facility management, study directors and quality assurance personnel on how the peer review of histopathology should be planned, managed, documented and reported in order to meet GLP expectations and requirements.

OECD Principles of Corporate Governance

OECD Principles of Corporate Governance PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264173706
Category :
Languages : en
Pages : 42

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Book Description
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.

OECD Series on Testing and Assessment Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453 Second edition

OECD Series on Testing and Assessment Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453 Second edition PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264221476
Category :
Languages : en
Pages : 156

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Book Description
This guidance provides additional information on the conduct of studies performed using Test Guidelines 451, 452 and Test Guideline 453.

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP) PDF Author: OECD
Publisher: OECD Publishing
ISBN: 9264304797
Category :
Languages : en
Pages : 206

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Book Description
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...

Good Laboratory Practice Training Manual

Good Laboratory Practice Training Manual PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 924154757X
Category : Medical
Languages : en
Pages : 265

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Book Description
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.

Handbook

Handbook PDF Author: World Health Organization
Publisher: World Health Organization
ISBN: 9241547553
Category : Medical
Languages : en
Pages : 328

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Book Description
A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian writings. One day love, in the shape of Félicien Hautecoeur, enters the dream world she has constructed around herself, bringing about upheaval and distress. Although it provides a detailed portrait of provincial 19th-century life and it adheres to a naturalist approach, The Dream eschews many of the characteristics of Zola's other novels of the Rougon-Macquart cycle—such as a pronounced polemical agenda or a gritty subject matter—offering instead a timeless, lyrical tale of love and innocence.

The Regulatory Compliance Almanac

The Regulatory Compliance Almanac PDF Author: Les Schnoll
Publisher: Paton Professional
ISBN: 9781932828191
Category : Law
Languages : en
Pages : 564

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Book Description


Food Contaminants and Residue Analysis

Food Contaminants and Residue Analysis PDF Author: Yolanda Picó
Publisher: Elsevier
ISBN: 0080931928
Category : Science
Languages : en
Pages : 848

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Book Description
Food Contaminants and Residue Analysis treats different aspects of the analysis of contaminants and residues in food and highlights some current concerns facing this field. The content is initiated by an overview on food safety, the objectives and importance of determining contaminants and residues in food, and the problems and challenges associated to these analyses. This is followed by full details of relevant EU and USA regulations. Topics, such as conventional chromatographic methods, accommodating cleanup, and preparing substances for further instrumental analysis, are encompassed with new analytical techniques that have been developed, significantly, over the past few years, like solid phase microextraction, liquid chromatography-mass spectrometry, immunoassays, and biosensors. A wide range of toxic contaminants and residues, from pesticides to mycotoxins or dioxins are examined, including polychlorinated biphenyls, polycyclic aromatic hydrocarbons, N-nitrosamines, heterocyclic amines, acrylamide, semicarbazide, phthalates and food packing migrating substances. This book can be a practical resource that offers ideas on how to choose the most effective techniques for determining these compounds as well as on how to solve problems or to provide relevant information. Logically structured and with numerous examples, Food Contaminants and Residue Analysis will be valuable a reference and training guide for postgraduate students, as well as a practical tool for a wide range of experts: biologists, biochemists, microbiologists, food chemists, toxicologists, chemists, agronomists, hygienists, and everybody who needs to use the analytical techniques for evaluating food safety.

A Guide to Archiving of Electronic Records

A Guide to Archiving of Electronic Records PDF Author: Tim Stiles
Publisher: Lulu.com
ISBN: 0955765927
Category : Language Arts & Disciplines
Languages : en
Pages : 42

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Book Description
The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.