Quality Assurance Implementation In Research Labs

Author : Akshay Anand
Publisher : Springer Nature
Page : 247 pages
File Size : 52,7 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”

Author : Mary D. Hinton
Publisher : Marcel Dekker
Page : 345 pages
File Size : 46,5 Mb
Release : 1995
Category : Science
ISBN : 0824794583

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Laboratory Information Management Systems by Mary D. Hinton Pdf

This practical resource discusses the fundamentals of laboratory information management systems (LIMS) and the steps required to develop a customized system or install an existing system - analyzing in detail the validation aspects of quality assurance and providing specific examples of LIMS validation methods. Written by an acknowledged LIMS expert and research chemist, Laboratory Information Management Systems is an incomparable hands-on guide for analytical chemists; quality and reliability managers and directors; industrial, manufacturing, process, design, cost, chemical, pharmaceutical, petroleum, and environmental engineers; laboratory information systems and management information systems managers; computer scientists; and upper-level undergraduate and graduate students in these disciplines.

Author : Philip Carson,Nigel Dent
Publisher : Royal Society of Chemistry
Page : 656 pages
File Size : 40,8 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 : United Nations Publications
Page : 42 pages
File Size : 43,9 Mb
Release : 2010
Category : Medical
ISBN : 9211482534

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Glossary of Terms for Quality Assurance and Good Laboratory Practices by Anonim Pdf

The field of quality assurance is beset by an extensive and sometimes confusing terminology, the use of which has still not been universally agreed on or accepted by laboratories or interested professional bodies worldwide. This glossary contains some of the most commonly used expressions in these fields, including those which appear in UNODC publications on quality assurance, and is an attempt to help promote and harmonise national efforts by providing internationally acceptable terminology. It is intended to be an aid to analysts in the implementation of quality assurance programmes and good laboratory practices, and is provided to laboratories as an educational document, and as a means of encouraging laboratories to collaborate and participate in quality assurance matters. As a result, the Glossary includes more than one definition of a word or phrase where these might improve understanding of what they mean. The current publication is an update of the first edition of the Glossary of Quality Assurance Terms. This second edition includes many new terms which have appeared in UNODC publications since the Glossary was first published.

Author : Gaffar Zaman
Publisher : BoD – Books on Demand
Page : 160 pages
File Size : 49,8 Mb
Release : 2018-08-22
Category : Business & Economics
ISBN : 9781789234121

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Quality Control in Laboratory by Gaffar Zaman Pdf

The book presents a qualitative and quantitative approach to understand, manage and enforce the integration of statistical concepts into quality control and quality assurance methods. Utilizing a sound theoretical and practical foundation and illustrating procedural techniques through scientific examples, this book bridges the gap between statistical quality control, quality assurance and quality management. Detailed procedures have been omitted because of the variety of equipment and commercial kits used in today's clinical laboratories. Instrument manuals and kit package inserts are the most reliable reference for detailed instructions on current analytical procedures.

Author : World Health Organization
Publisher : Unknown
Page : 0 pages
File Size : 43,8 Mb
Release : 2011
Category : Laboratories
ISBN : 9241548274

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Laboratory Quality Management System by World Health Organization Pdf

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 : D. Brynn Hibbert
Publisher : Oxford University Press
Page : 320 pages
File Size : 48,8 Mb
Release : 2007-03-29
Category : Science
ISBN : 0198036728

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Quality Assurance in the Analytical Chemistry Laboratory by D. Brynn Hibbert Pdf

Analytical chemical results touch everyones lives can we eat the food? do I have a disease? did the defendant leave his DNA at the crime scene? should I invest in that gold mine? When a chemist measures something how do we know that the result is appropriate? What is fit for purpose in the context of analytical chemistry? Many manufacturing and service companies have embraced traditional statistical approaches to quality assurance, and these have been adopted by analytical chemistry laboratories. However the right chemical answer is never known, so there is not a direct parallel with the manufacture of ball bearings which can be measured and assessed. The customer of the analytical services relies on the quality assurance and quality control procedures adopted by the laboratory. It is the totality of the QA effort, perhaps first brought together in this text, that gives the customer confidence in the result. QA in the Analytical Chemistry Laboratory takes the reader through all aspects of QA, from the statistical basics and quality control tools to becoming accredited to international standards. The latest understanding of concepts such as measurement uncertainty and metrological traceability are explained for a working chemist or her client. How to design experiments to optimize an analytical process is included, together with the necessary statistics to analyze the results. All numerical manipulation and examples are given as Microsoft Excel spreadsheets that can be implemented on any personal computer. Different kinds of interlaboratory studies are explained, and how a laboratory is judged in proficiency testing schemes is described. Accreditation to ISO 17025 or OECD GLP is nearly obligatory for laboratories of any pretension to quality. Here the reader will find an introduction to the requirements and philosophy of accreditation. Whether completing a degree course in chemistry or working in a busy analytical laboratory, this book is a single source for an introduction into quality assurance.

Author : Thomas A. Ratliff
Publisher : Wiley-Interscience
Page : 248 pages
File Size : 49,9 Mb
Release : 2003-03-31
Category : Technology & Engineering
ISBN : 0471269182

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The Laboratory Quality Assurance System by Thomas A. Ratliff Pdf

Both the 17025:1999 standard and especially ANSI/ISO/ASQ,9001-2000 standard require that a laboratory document its procedures for obtaining reliable results. The Laboratory Quality Assurance Manual details to the user how to a prepare a new laboratory quality assurance manual, which will be appropriate to use as a procedures manual for a particular laboratory, a sales tool to attract potential customers, a document that can be to answer regulatory questions, and ultimately a tool to become a registered ISO 9001/2000 Lab and gain related certifications based on the standard. The Laboratory Quality Assurance Manual: -Incoporates changes to ANSI/ISO/ASQ 9001-2000 pertaining to laboratories. -Provides blank forms used in preparing a quality manual. -Provides information on the interrelationship of ANSI/ISO 17025:1999 and ANSI/ISO/ASQ 9001-2000.

Author : Bernd W. Wenclawiak,Michael Koch,Evsevios Hadjicostas
Publisher : Springer
Page : 611 pages
File Size : 46,6 Mb
Release : 2013-12-20
Category : Science
ISBN : 9783662096215

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Quality Assurance in Analytical Chemistry by Bernd W. Wenclawiak,Michael Koch,Evsevios Hadjicostas Pdf

Quality Assurance in Chemical Measurement, an advanced EURACHEM textbook, provides in-depth but easy-to-understand coverage for training, teaching and continuing studies. The CD-ROM accompanying the book contains course materials produced by ten experienced specialists, including more than 750 overheads (graphics and text) in ready-to-use PowerPoint® documents in English and German language. The book will serve as an advanced textbook for analytical chemistry students and professionals in industry and service labs and as a reference text and source of course materials for lecturers. The second edition has been completely revised according to the newest legislation.

Author : Frederick M. Garfield,Eugene Klesta,Jerry Hirsch
Publisher : Association of Official Analytical Chemist
Page : 200 pages
File Size : 51,8 Mb
Release : 2000
Category : Medical
ISBN : UOM:39015055077930

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Quality Assurance Principles for Analytical Laboratories by Frederick M. Garfield,Eugene Klesta,Jerry Hirsch Pdf

Author : Anonim
Publisher : CRC Press
Page : 250 pages
File Size : 52,8 Mb
Release : 2016-04-19
Category : Science
ISBN : 9781420082715

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Quality Assurance and Quality Control in the Analytical Chemical Laboratory by Anonim Pdf

A Practical Tool for Learning New Methods Quality assurance and measurement uncertainty in analytical laboratories has become increasingly important. To meet increased scrutiny and keep up with new methods, practitioners very often have to rely on self-study. A practical textbook for students and a self-study tool for analytical laboratory employees, Quality Assurance and Quality Control in the Analytical Chemical Laboratory: A Practical Approach defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Unified Coverage of QA in Analytical Chemistry Clearly written and logically organized, this book delineates the concepts of practical QA/QC, taking a generic approach that can be applied to any field of analysis. Using an approach grounded in hands-on experience, the book begins with the theory behind quality control systems and then moves on to discuss examples of tools such as validation parameter measurements, the use of statistical tests, counting the margin of error, and estimating uncertainty. The authors draw on their experience in uncertainty estimation, traceability, reference materials, statistics, proficiency tests, and method validation to provide practical guidance on each step of the process. Extended Coverage of QC/QA in Analytical and Testing Laboratories Presenting guidance on all aspects of QA and measurement results, the book covers QC/QA in a more complex and extended manner than other books on this topic. This range of coverage supplies an integrated view on measures like the use of reference materials and method validation. With worked-out examples and Excel spreadsheets that users can use to try the concepts themselves, the book provides not only know-what but know-how.

Author : National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Committee on Science, Engineering, Medicine, and Public Policy,Committee on Responsible Science
Publisher : National Academies Press
Page : 327 pages
File Size : 54,6 Mb
Release : 2018-01-13
Category : Science
ISBN : 9780309391252

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Fostering Integrity in Research by National Academies of Sciences, Engineering, and Medicine,Policy and Global Affairs,Committee on Science, Engineering, Medicine, and Public Policy,Committee on Responsible Science Pdf

The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.

Author : Piotr Konieczka,Jacek Namiesnik
Publisher : CRC Press
Page : 325 pages
File Size : 47,9 Mb
Release : 2018-03-26
Category : Science
ISBN : 9781315294995

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Quality Assurance and Quality Control in the Analytical Chemical Laboratory by Piotr Konieczka,Jacek Namiesnik Pdf

The second edition defines the tools used in QA/QC, especially the application of statistical tools during analytical data treatment. Clearly written and logically organized, it takes a generic approach applicable to any field of analysis. The authors begin with the theory behind quality control systems, then detail validation parameter measurements, the use of statistical tests, counting the margin of error, uncertainty estimation, traceability, reference materials, proficiency tests, and method validation. New chapters cover internal quality control and equivalence method, changes in the regulatory environment are reflected throughout, and many new examples have been added to the second edition.

Author : Frederick M. Garfield
Publisher : Association of Official Analytical Chemist
Page : 214 pages
File Size : 44,9 Mb
Release : 1991
Category : Science
ISBN : UOM:39015051247412

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Quality Assurance Principles for Analytical Laboratories by Frederick M. Garfield Pdf

Quality assurance planning. statistical applications and control charts. Personel considerations. Management of equipment and supplies. Sample and record handling. Sampling and sample analysis. Proficiency and check samples. Audit procedures. Design and safety of facilities. Laboratory accreditation.

Author : J. Dux
Publisher : Springer Science & Business Media
Page : 205 pages
File Size : 43,7 Mb
Release : 2013-11-11
Category : Medical
ISBN : 9781475753776

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Handbook of Quality Assurance for the Analytical Chemistry Laboratory by J. Dux Pdf

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 Quality, Quality 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.