Laboratory Accreditation and Data Certification


Book Description

This book provides descriptions of current laboratory accreditation schemes and explains why these schemes fall short of assuring data purchasers that the data produced from accredited laboratories are always quality products. The book then presents a system for laboratory accreditation in conjunction with data certification that assures data purchasers their data are useful for the purposes for which they are intended. Simple quality assurance and quality control techniques, in addition to concepts of total quality management, are described and then applied to the environmental laboratory industry. This "System For Success" was developed from real problems and real solutions within the industry and represents an integration of proven techniques that offer a better way to ensure quality laboratory data is obtained. Laboratory Accreditation: A Workable Solution is a must for government officials, environmental professionals, independent environmental laboratories, hazardous waste disposal industries, chemical manufacturers, QA professionals, and testing laboratories.




Laboratory Accreditation and Data Certification


Book Description

This book provides descriptions of current laboratory accreditation schemes and explains why these schemes fall short of assuring data purchasers that the data produced from accredited laboratories are always quality products. The book then presents a system for laboratory accreditation in conjunction with data certification that assures data purchasers their data are useful for the purposes for which they are intended. Simple quality assurance and quality control techniques, in addition to concepts of total quality management, are described and then applied to the environmental laboratory industry. This "System For Success" was developed from real problems and real solutions within the industry and represents an integration of proven techniques that offer a better way to ensure quality laboratory data is obtained. Laboratory Accreditation: A Workable Solution is a must for government officials, environmental professionals, independent environmental laboratories, hazardous waste disposal industries, chemical manufacturers, QA professionals, and testing laboratories.










Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences


Book Description

The Handbook of Data Recording, Maintenance, and Management for the Biomedical Sciences explains how to maintain a scientific log that will withstand peer, federal, and other reviewing agencies' scrutiny. This is a timely publication as the maintenance of a log becomes an increasingly more important issue. It covers data monitoring, recording and maintenance; quality assurance; and printed forms, and the laws and regulations that impact their design and use.







GALP Regulatory Handbook


Book Description

The GALP Regulatory Handbook is an easy-to-use manual to assist laboratories in applying the Good Automated Laboratory Practice guidelines published by the Environmental Protection Agency in 1990. The proliferation of computerized data collection has resulted in new problems of corruption, loss, and inappropriate modification in data provided to the EPA. The EPA published its GALP guidelines to aid laboratories replacing manual operations with computer technology. The eight chapters of this handbook provide a "how-to" framework for complying with those guidelines. The book looks at the extent and seriousness of those control issues for automated data collection systems, the intent of the GALPs in solving and preventing those problems, and the implementation guidelines that can help laboratory management maintain the compliance and quality that are fundamental to effective operation.




Laboratory Quality Management System


Book Description

Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook was developed through collaboration between the WHO Lyon Office for National Epidemic Preparedness and Response, the United States of America Centers for Disease Control and Prevention (CDC) Division of Laboratory Systems, and the Clinical and Laboratory Standards Institute (CLSI). It is based on training sessions and modules provided by the CDC and WHO in more than 25 countries, and on guidelines for implementation of ISO 15189 in diagnostic laboratories, developed by CLSI. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. Each topic is discussed in a separate chapter. The chapters follow the framework developed by CLSI and are organized as the "12 Quality System Essentials".




Management of Animal Care and Use Programs in Research, Education, and Testing


Book Description

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).