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Author: Isin Akyar Publisher: BoD – Books on Demand ISBN: 9533076836 Category : Technology & Engineering Languages : en Pages : 548
Book Description
Quality control is a standard which certainly has become a style of living. With the improvement of technology every day, we meet new and complicated devices and methods in different fields. Quality control explains the directed use of testing to measure the achievement of a specific standard. It is the process, procedures and authority used to accept or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products, and the authority to review production records to assure that no errors have occurred.The quality which is supposed to be achieved is not a concept which can be controlled by easy, numerical or other means, but it is the control over the intrinsic quality of a test facility and its studies. The aim of this book is to share useful and practical knowledge about quality control in several fields with the people who want to improve their knowledge.
Author: Isin Akyar Publisher: BoD – Books on Demand ISBN: 9533076836 Category : Technology & Engineering Languages : en Pages : 548
Book Description
Quality control is a standard which certainly has become a style of living. With the improvement of technology every day, we meet new and complicated devices and methods in different fields. Quality control explains the directed use of testing to measure the achievement of a specific standard. It is the process, procedures and authority used to accept or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products, and the authority to review production records to assure that no errors have occurred.The quality which is supposed to be achieved is not a concept which can be controlled by easy, numerical or other means, but it is the control over the intrinsic quality of a test facility and its studies. The aim of this book is to share useful and practical knowledge about quality control in several fields with the people who want to improve their knowledge.
Author: Publisher: ISBN: 9789241597852 Category : Languages : en Pages :
Book Description
In 2006, WHO/TDR convened a meeting of organizations engaged in clinical trials in disease endemic countries to discuss the applicability of GCLP guidelines to their work. It was agreed that GCLP would be a valuable tool for improving quality laboratory practice. In line with that agreement, TDR/WHO recently acquired copyright to GCLP guidelines that were originally published in 2003 by a working party of the Clinical Committee of the British Association of Research Quality Assurance (BARQA), with the aim of disseminating them widely in developing countries and developing related training materials. These GCLP guidelines are presented here. Compliance with them will allow clinical laboratories to ensure that safety and efficacy data is repeatable, reliable, auditable and easily reconstructed in a research setting. GCLP guidelines set a standard for compliance by laboratories involved in the analysis of samples from TDR-supported clinical trials.
Author: Philip Carson Publisher: Royal Society of Chemistry ISBN: 1847557724 Category : Science Languages : en Pages : 657
Book Description
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: Susan Mahler Zneimer Publisher: John Wiley & Sons ISBN: 1119069742 Category : Science Languages : en Pages : 844
Book Description
Cytogenetic Laboratory Management Cytogenetic Laboratory Management Chromosomal, FISH and Microarray-Based Best Practices and Procedures Cytogenetic Laboratory Management: Chromosomal, FISH and Microarray-Based Best Practices and Procedures is a practical guide that describes how to develop and implement best practice processes and procedures in the genetic laboratory setting. The text first describes good laboratory practices, including quality management, design control of tests, and FDA guidelines for laboratory-developed tests, and preclinical validation study designs. The second focus of the book is on best practices for staffing and training, including cost of testing, staffing requirements, process improvement using Six Sigma techniques, training and competency guidelines, and complete training programs for cytogenetic and molecular genetic technologists. The third part of the text provides stepwise standard operating procedures for chromosomal, FISH and microarray-based tests, including preanalytic, analytic, and postanalytic steps in testing, which are divided into categories by specimen type and test type. All three sections of the book include example worksheets, procedures, and other illustrative examples that can be downloaded from the Wiley website to be used directly without having to develop prototypes in your laboratory. Providing a wealth of information on both laboratory management and molecular and cytogenetic testing, Cytogenetic Laboratory Management will be an essential tool for laboratorians worldwide in the field of laboratory testing and genetic testing in particular. This book gives the essentials of: Developing and implementing good quality management programs in laboratories Understanding design control of tests and preclinical validation studies and reports FDA guidelines for laboratory-developed tests Use of reagents, instruments, and equipment Cost of testing assessment and process improvement using Six Sigma methodology Staffing training and competency objectives Complete training programs for molecular and cytogenetic technologists Standard operating procedures for all components of chromosomal analysis, FISH, and microarray testing of different specimen types This volume is a companion to Cytogenetic Abnormalities: Chromosomal, FISH and Microarray-Based Clinical Reporting. The combined volumes give an expansive approach to performing, reporting, and interpreting cytogenetic laboratory testing and the necessary management practices, staff and testing requirements.
Author: Sollecito Publisher: Jones & Bartlett Publishers ISBN: 1449677487 Category : Medical Languages : en Pages : 624
Book Description
. Through a unique interdisciplinary perspective on quality management in health care, this text covers the subjects of operations management, organizational behavior, and health services research. With a particular focus on Total Quality Management and Continuous Quality Improvement, the challenges of implementation and institutionalization are addressed using examples from a variety of health care organizations, including primary care clinics, hospital laboratories, public health departments, and academic health centers. Important Notice: The digital edition of this book is missing some of the images or content found in the physical edition
Author: Isin Akyar Publisher: IntechOpen ISBN: 9789533076836 Category : Technology & Engineering Languages : en Pages : 546
Book Description
Quality control is a standard which certainly has become a style of living. With the improvement of technology every day, we meet new and complicated devices and methods in different fields. Quality control explains the directed use of testing to measure the achievement of a specific standard. It is the process, procedures and authority used to accept or reject all components, drug product containers, closures, in-process materials, packaging material, labeling and drug products, and the authority to review production records to assure that no errors have occurred.The quality which is supposed to be achieved is not a concept which can be controlled by easy, numerical or other means, but it is the control over the intrinsic quality of a test facility and its studies. The aim of this book is to share useful and practical knowledge about quality control in several fields with the people who want to improve their knowledge.
Author: Michael J. McGraw Publisher: Pharmaceutical Press ISBN: 0853697906 Category : Business & Economics Languages : en Pages : 273
Book Description
Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309475201 Category : Medical Languages : en Pages : 399
Book Description
When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.
Author: Isin Akyar
Author: Isin Akyar
Author: 
Author: Tim Stiles
Author: Philip Carson
Author: Susan Mahler Zneimer
Author: Sollecito
Author: David Hutchinson
Author: Isin Akyar
Author: Michael J. McGraw
Author: National Academies of Sciences, Engineering, and Medicine