Download or read book 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 written by OECD and published by OECD Publishing. This book was released on 2007-06-11 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Guidance on the GLP Requirements for Peer Review of Histopathology written by OECD and published by OECD Publishing. This book was released on 2015-01-02 with total page 11 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Download or read book Animal Cell Culture written by John M. Davis and published by John Wiley & Sons. This book was released on 2011-03-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive research guide that describes both the key new techniques and more established methods. Every chapter discusses the merits and limitations of the various approaches and then provides selected tried-and-tested protocols, as well as a plethora of good practical advice, for immediate use at the bench. It presents the most accessible and comprehensive introduction available to the culture and experimental manipulation of animal cells. Detailed protocols for a wide variety of methods provide the core of each chapter, making new methodology easily accessible. This book is an essential laboratory manual for all undergraduates and graduates about to embark on a cell culture project. It is a book which both experienced researchers and those new to the field will find invaluable.
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.
Download or read book 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 written by OECD and published by OECD Publishing. This book was released on 2014-09-03 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance provides additional information on the conduct of studies performed using Test Guidelines 451, 452 and Test Guideline 453.
Download or read book OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices GIVIMP written by OECD and published by OECD Publishing. This book was released on 2018-12-10 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 ...
Download or read book OECD Guidelines for Testing of Chemicals written by Organisation for Economic Co-operation and Development and published by Organisation for Economic Co-operation and Development ; [Montréal : Renouf]. This book was released on 1981 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
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.
Download or read book Modern Approaches To Quality Control written by Ahmed Badr Eldin and published by BoD – Books on Demand. This book was released on 2011-11-09 with total page 554 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid advance have been made in the last decade in the quality control procedures and techniques, most of the existing books try to cover specific techniques with all of their details. The aim of this book is to demonstrate quality control processes in a variety of areas, ranging from pharmaceutical and medical fields to construction engineering and data quality. A wide range of techniques and procedures have been covered.
Download or read book The Regulatory Compliance Almanac written by Les Schnoll and published by Paton Professional. This book was released on 2008 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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
Download or read book Handbook written by World Health Organization and published by World Health Organization. This book was released on 2010-02-02 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Food Contaminants and Residue Analysis written by Yolanda Picó and published by Elsevier. This book was released on 2008-09-10 with total page 848 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book GDPR and Biobanking written by Jane Reichel and published by Springer Nature. This book was released on 2021 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part I Setting the scene -- Introduction: Individual rights, the public interest and biobank research 4000 (8) -- Genetic data and privacy protection -- Part II GDPR and European responses -- Biobank governance and the impact of the GDPR on the regulation of biobank research -- Controller' and processor's responsibilities in biobank research under GDPR -- Individual rights in biobank research under GDPR -- Safeguards and derogations relating to processing for archiving purposes in the scientific purposes: Article 89 analysis for biobank research -- A Pan-European analysis of Article 89 implementation and national biobank research regulations -- EEA, Switzerland analysis of GDPR requirements and national biobank research regulations -- Part III National insights in biobank regulatory frameworks -- Selected 10-15 countries for reports: Germany -- Greece -- France -- Finland -- Sweden -- United Kingdom -- Part IV Conclusions -- Reflections on individual rights, the public interest and biobank research, ramifications and ways forward. .
Download or read book A Guide to Archiving of Electronic Records written by Tim Stiles and published by Lulu.com. This book was released on 2014 with total page 42 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Wide Spectra of Quality Control written by Isin Akyar and published by . This book was released on 2011 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality control is a standard which certainly has become a style of living. With the improvement of technology every day, we meet new and complicated devices and methods in different fields. Quality control explains the directed use of testing to measure the achievement of a specific standard. It is the process, procedures and authority used to accept or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products, and the authority to review production records to assure that no errors have occurred.The quality which is supposed to be achieved is not a concept which can be controlled by easy, numerical or other means, but it is the control over the intrinsic quality of a test facility and its studies. The aim of this book is to share useful and practical knowledge about quality control in several fields with the people who want to improve their knowledge.
