Good Laboratory Practice Training Manual

Author : World Health Organization
Publisher : World Health Organization
Page : 265 pages
File Size : 46,9 Mb
Release : 2010-02-02
Category : Medical
ISBN : 9789241547574

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Good Laboratory Practice Training Manual by World Health Organization Pdf

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.

Author : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 51,9 Mb
Release : 2010
Category : Medical
ISBN : 9241547561

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Good Laboratory Practice Training Manual by World Health Organization Pdf

This manual is aimed at trainers of good laboratory practice (GLP) and is a companion manual to the GLP training manual for the trainee.

Author : Sandy Weinberg
Publisher : CRC Press
Page : 249 pages
File Size : 52,8 Mb
Release : 2002-11-06
Category : Medical
ISBN : 9780203911082

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Good Laboratory Practice Regulations, Revised and Expanded by Sandy Weinberg Pdf

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 : Sandy Weinberg
Publisher : CRC Press
Page : 304 pages
File Size : 43,8 Mb
Release : 2007-01-19
Category : Medical
ISBN : 9780849375842

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Good Laboratory Practice Regulations by Sandy Weinberg Pdf

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 : Milton A. Anderson
Publisher : CRC Press
Page : 67 pages
File Size : 47,7 Mb
Release : 2002
Category : Medical
ISBN : 1574911384

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GLP Essentials by Milton A. Anderson Pdf

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.

Author : Syed Imtiaz Haider,Syed Erfan Asif
Publisher : CRC Press
Page : 484 pages
File Size : 55,9 Mb
Release : 2016-04-19
Category : Medical
ISBN : 9781439850169

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Quality Control Training Manual by Syed Imtiaz Haider,Syed Erfan Asif Pdf

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences

Author : World Health Organization
Publisher : World Health Organization
Page : 328 pages
File Size : 40,6 Mb
Release : 2010-02-02
Category : Medical
ISBN : 9789241547550

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Handbook by World Health Organization Pdf

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.

Author : Jürg P. Seiler
Publisher : Springer Science & Business Media
Page : 433 pages
File Size : 48,6 Mb
Release : 2006-01-16
Category : Medical
ISBN : 9783540282341

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Good Laboratory Practice by Jürg P. Seiler Pdf

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 studies 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 : United States. Food and Drug Administration
Publisher : Unknown
Page : 60 pages
File Size : 48,7 Mb
Release : 1979
Category : Laboratories
ISBN : UCAL:C3121445

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Good Laboratory Practice Regulations Management Briefings by United States. Food and Drug Administration Pdf

Author : Shein-Chung Chow
Publisher : CRC Press
Page : 2434 pages
File Size : 41,9 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9781351110266

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Encyclopedia of Biopharmaceutical Statistics - Four Volume Set by Shein-Chung Chow Pdf

Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.

Author : Mark A. Suckow,Bill Yates
Publisher : Academic Press
Page : 344 pages
File Size : 53,5 Mb
Release : 2015-06-14
Category : Medical
ISBN : 9780124200654

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Research Regulatory Compliance by Mark A. Suckow,Bill Yates Pdf

Research Regulatory Compliance offers the latest information on regulations and compliance in the laboratory. With the increasing complexity of regulations and need for institutional infrastructure to deal with compliance of animal use issues, as well as a requirement surrounding human subjects, this publication provides reputable guidance and information. The book is extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and is also a great asset for faculty or new researchers coming in to the laboratory environment. It will help prepare users for the deluge of regulatory and compliance issues they will face while conducting their scientific programs. The book is edited and authored by known leaders in the field of compliance and regulations, and contains extensive research on the topics. It represents the new standard for information in every laboratory. Provides a “one-stop" , go-to resource for the many regulatory and compliance issues that affect laboratory study and research models Extremely helpful as a resource for researchers, administrators, and technicians in the laboratory, and also a great asset for faculty or new researchers coming in to the laboratory environment Focuses on United States regulations, covering both animal models and human subjects Written and edited by known leaders in the field of regulatory compliance who bring many years of collective experience to the book

Author : Pawan Bharati Kumar
Publisher : Discovery Publishing House Pvt Limited
Page : 326 pages
File Size : 41,7 Mb
Release : 2020-04
Category : Education
ISBN : 9388854373

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LABORATORY MANAGEMENT SYSTEM - GENERAL REQUIREMENTS by Pawan Bharati Kumar Pdf

The present book updates the subject content on Laboratory Management System; Effective Handling of Lab Instruments and Chemicals, Safety in Microbiology Laboratory, Cultivation of Great Work Habits; Quality Management Systems (QMS) - Requirements (ISO 9001:2015); Environmental Management Systems (EMS) ISO-14001 - Requirements with guidance, Occupational Health and Safety Management Systems (OHSAS-18001): Requirements; Integrated Management System (IMS) Manual; Good Laboratory Practice (GLP) Training Manual and Guidelines; OECD Principles of GLP.

Author : Philip Carson,Nigel Dent
Publisher : Royal Society of Chemistry
Page : 656 pages
File Size : 44,8 Mb
Release : 2007-10-31
Category : Science
ISBN : 9781847557728

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Good Clinical, Laboratory and Manufacturing Practices by Philip Carson,Nigel Dent Pdf

Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Author : Anonim
Publisher : Unknown
Page : 428 pages
File Size : 53,7 Mb
Release : 2006
Category : Tropical medicine
ISBN : UCBK:C095486551

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TDR News by Anonim Pdf

Author : Akshay Anand
Publisher : Springer Nature
Page : 247 pages
File Size : 53,7 Mb
Release : 2021-08-17
Category : Medical
ISBN : 9789811630743

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Quality Assurance Implementation in Research Labs by Akshay Anand Pdf

This book is a comprehensive and timely compilation of strategy, methods, and implementation of a proof of concept modified quality module of Good Laboratory Practices (GLP). This text provides a historical overview of GLP and related standards of quality assurance practices in clinical testing laboratories as well as basic research settings. It specifically discusses the need and challenges in audit, documentation, and strategies for its implications in system-dependent productivity striving research laboratories. It also describes the importance of periodic training of study directors as well as the scholars for standardization in research processes. This book describes different documents required at various time points of a successful Ph.D and post-doc tenure along with faculty training besides entire lab establishments. Various other areas including academic social responsibility and quality assurance in the developing world, lab orientations, and communication, digitization in data accuracy, auditability and back traceability have also been discussed. This book will be a preferred source for principal investigators, research scholars, and industrial research centers globally. From the foreword by Ratan Tata, India “This book will be a guide for students and professionals alike in quality assurance practices related to clinical research labs. The historical research and fundamental principles make it a good tool in clinical research environments. The country has a great need for such a compilation in order to increase the application of domestic capabilities and technology”