A Laboratory Quality Handbook Of Best Practices
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| Author | : Donald C. Singer |
| Publisher | : Quality Press |
| Total Pages | : 401 |
| Release | : 2001-09-25 |
| Genre | : Business & Economics |
| ISBN | : 0873891090 |
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. From sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance. Contents: Quality Assurance in the Laboratory, History of Regulation, Training in the Laboratory, Laboratory Documentation and Data, Sample Control and LIM Systems, Methods Validation
| Author | : World Health Organization |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2011 |
| Genre | : Laboratories |
| ISBN | : 9789241548274 |
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".
| Author | : Philip Carson |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 657 |
| Release | : 2007-10-31 |
| Genre | : Science |
| ISBN | : 1847557724 |
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 | : J. Dux |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 207 |
| Release | : 2012-12-06 |
| Genre | : Science |
| ISBN | : 1468414585 |
xii a second edition might be in order, and readily agreed. Although the basic principles remain the same, discussions with analysts, laboratory supervisors, and managers indicated many areas where improve ments could be made. For example, new chapters have been added on sampling and quality assurance; laboratory facilities and quality assurance; and auditing for quality assurance. Very little of the first edition has been discarded, but many topics have been expanded considerably. The chapter on computers has been completely rewritten in view of the rapid changes in that field. The chapter in the first edition on planning and organizing for quality assurance has been split into two chapters, one on planning for quality assurance and the other on organizing and establishing a quality assurance program, and new material on mandated quality assurance programs has been combined with the material on laboratory accreditation. Numerous examples, especially those involving mathematical calculations, have been added at the suggestion of some readers. In short, this edition is very nearly a new book, and I can only hope it is as well received as the first edition. CHAPTER 1 Qual ity, Qual ity Control, and Quality Assurance One of the strongest trends in modem society is the continuing ev olution from a manufacturing to a service-oriented economy.
| Author | : Moumtzoglou, Anastasius S. |
| Publisher | : IGI Global |
| Total Pages | : 346 |
| Release | : 2019-11-29 |
| Genre | : Medical |
| ISBN | : 1799823911 |
There is a significant deficiency among contemporary medicine practices reflected by experts making medical decisions for a large proportion of the population for which no or minimal data exists. Fortunately, our capacity to procure and apply such information is rapidly rising. As medicine becomes more individualized, the implementation of health IT and data interoperability become essential components to delivering quality healthcare. Quality Assurance in the Era of Individualized Medicine is a collection of innovative research on the methods and utilization of digital readouts to fashion an individualized therapy instead of a mass-population-directed strategy. While highlighting topics including assistive technologies, patient management, and clinical practices, this book is ideally designed for health professionals, doctors, nurses, hospital management, medical administrators, IT specialists, data scientists, researchers, academicians, and students.
| Author | : Sandy Weinberg |
| Publisher | : CRC Press |
| Total Pages | : 249 |
| Release | : 2002-11-06 |
| Genre | : Medical |
| ISBN | : 0203911083 |
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 | : Donald C. Singer |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2001 |
| Genre | : Laboratories |
| ISBN | : 9780873894913 |
Based on the work of a collection of experts from the laboratory science and quality assurance fields, A Laboratory Quality Handbook of Best Practices and Relevant Regulations provides all of the information needed to run a successful laboratory that is in compliance with all regulations. from sample tracking to accurate documentation, training to methods validation, maintenance to calibration, and out-of-spec responses to preparation for audits, a combination of people, instrumentation and documentation must work in sync for high quality results. This handbook provides information that will help a laboratory achieve high quality results and compliance.
| Author | : Donnell R. Christian Jr. |
| Publisher | : CRC Press |
| Total Pages | : 1434 |
| Release | : 2009-11-24 |
| Genre | : Business & Economics |
| ISBN | : 1420073052 |
In order to gain accreditation, every laboratory must have a superior quality assurance program. The keys to a successful program are the operational and technical manuals and associated documents which define the program and its various components. Written by experts with global experience in setting up laboratories, Implementing Quality in Labora
| Author | : Steve Kitchen |
| Publisher | : John Wiley & Sons |
| Total Pages | : 325 |
| Release | : 2011-08-24 |
| Genre | : Medical |
| ISBN | : 1444360590 |
"Over the last decades, major progress has been made in quality assurance of hemostatic laboratory assays. This book will be an indispensable part of every hemostasis laboratory, where, given its hands-on nature, it will rarely sit to get dusty on the shelves." —Frits R. Rosendaal, Leiden University Medical Center The hemostasis laboratory has a vital role in the diagnosis and management of patients with familial and acquired hemorrhagic and thrombotic disorders. Its role in the monitoring traditional anticoagulant therapy as well as therapy using new anticoagulants presents new challenges to the laboratory. Quality in Laboratory Hemostasis and Thrombosis not only addresses these important issues, but also covers international guidelines for testing, the development of international standard materials, management of hemostasis testing from the laboratory to the point of care as well as molecular genetic testing. Designed as a guide for all those working in hemostasis laboratories, this book details a quality program that, when put into place, will help to improve standards in testing. All of the authors are internationally recognised for their work in hemostasis and thrombosis. Using their experience, they provide information on standards, equipment and methods that will guide the development of a quality program to support all activities in the hemostasis laboratory.
| Author | : Michael R. McGinnis |
| Publisher | : Elsevier |
| Total Pages | : 678 |
| Release | : 2012-12-02 |
| Genre | : Medical |
| ISBN | : 0323138861 |
Laboratory Handbook of Medical Mycology summarizes the concepts dealing with the laboratory aspects of medical mycology. The publication first offers information on basic terminology and classification, laboratory safety, and clinical specimens. Discussions focus on tissue, abscess, blood, bone marrow, and urine specimens, biological hazards, disinfection and sterilization, grounding of electrical equipment, waste disposal, asexual and sexual reproduction, and vegetative growth. The text then takes a look at mold and yeast identification, including fermentation, temperature studies, asci and ascospores, zygomycetes, cycloheximide resistance, and sporulation and sterile isolates. The manuscript ponders on susceptibility testing and bioassay procedures, culture collection, and quality control. Topics include proficiency evaluations, media and equipment control, depositing unusual isolates in major culture collections, reconstituting lyophilized cultures, bioassay to determine drug levels in body fluids, and in vitro susceptibility testing. The publication is a dependable source of data for laboratory technologists, microbiologists, and mycologists engaged in safely isolating and accurately identifying fungi of medical importance.
