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Author: William F. Salminen
Publisher: Academic Press
ISBN: 0123978319
Category : Technology & Engineering
Languages : en
Pages : 263
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Book Description
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. - Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step - Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues - Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process - Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book
Author: William F. Salminen
Publisher: Academic Press
ISBN: 0123978319
Category : Technology & Engineering
Languages : en
Pages : 263
Get Book Here
Book Description
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny. - Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step - Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues - Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process - Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book
Author: Graham P. Bunn
Publisher: CRC Press
ISBN: 1000789594
Category : Medical
Languages : en
Pages : 179
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Book Description
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
Author: Akshay Anand
Publisher: Springer Nature
ISBN: 9811630747
Category : Medical
Languages : en
Pages : 247
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Book Description
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”
Author: Kathleen E. McCormick
Publisher: Butterworth-Heinemann
ISBN: 0323994601
Category : Technology & Engineering
Languages : en
Pages : 385
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Book Description
Quality, second edition, provides comprehensive application of regulatory guidelines and quality concepts and methodologies related to pharmaceutical manufacturing. It is an excellent resource for practitioners, those pursuing pharmaceutical related certifications, and for students trying to learn more about pharmaceutical manufacturing. This book provides the background theory, applied descriptions of the guidelines and concepts, plus questions and problems at the end of the chapters that will help provide practice for the reader to apply the concepts. In this book the authors share their combined 60+ years of extensive practical experience in the industry and in process improvement combined with detailed understanding of the needs of the industry and education system. This book provides real-life examples from industry and guidelines for practical application of tools that can be referenced by operators, engineers, and management.This book is fully revised, updated, and expanded with new content in areas such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools. - Fully revised, updated, and expanded new edition - Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools - Includes end-of-chapter summaries and end-of-chapter question and/or problems - Provides detailed steps and examples for applying the guidelines and quality tools - Written in an accessible style making the content easy to understand and apply
Author: William J. Brock
Publisher: John Wiley & Sons
ISBN: 1118370392
Category : Science
Languages : en
Pages : 568
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Book Description
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Author: Doanld C. Singer
Publisher: CRC Press
ISBN: 1498710522
Category : Technology & Engineering
Languages : en
Pages : 430
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Book Description
This single-source reference provides practical guidance for the quality auditing of a chemical or biological testing laboratory-helping to develop or improve quality control and quality assurance programs in order to meet certification standards or pass external-source audits.
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.
Author: Mark A. Suckow
Publisher: Academic Press
ISBN: 0124200656
Category : Medical
Languages : en
Pages : 345
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Book Description
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: 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.
Author: Andrew J Connolly
Publisher: Elsevier Health Sciences
ISBN: 0323287808
Category : Medical
Languages : en
Pages : 403
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Book Description
A mainstay for pathology residents, Autopsy Pathology is designed with a uniquely combined manual and atlas format that presents today's most complete coverage of performing, interpreting, and reporting post-mortem examinations. This lasting and useful medical reference book offers a practical, step-by-step approach to discussing not only the basics of the specialty, but the performance of specialized autopsy procedures as well. Material is divided into two sections for ease of use: a manual covering specific autopsy procedures, biosafety, generation of autopsy reports, preparation of death certificates, and other essential subjects; and an atlas, organized by organ system, which captures the appearance of the complete spectrum of autopsy findings. Offers expanded coverage of microscopic anatomy. Includes a chapter on performing special dissection procedures that may not be covered during a typical residency. Examines important techniques, such as autopsy photography and radiology, microscopic examination, supplemental laboratory studies, and other investigative approaches. Addresses the latest legal, social, and ethical issues relating to autopsies, as well as quality improvement and assurance. Presents more than 600 full-color photographs depicting common gross and microscopic autopsy findings for every part of the body. Correlates pathologic findings with their clinical causes to enhance diagnostic accuracy. Improved images in the Atlas section provide greater visual understanding. Additional online features include dissection videos demonstrating autopsy techniques; downloadable, commonly used forms for autopsy reports; and calculators for weights and measures. Expert Consult eBook version included with purchase. This enhanced eBook experience offers access to all of the text, figures, images, videos, forms, calculators, and references from the book on a variety of devices.
