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Development of a professional quality assurance society – the SQA model 发展专业的质量保证协会——SQA模式
Quality Assurance Journal Pub Date : 2006-03-01 DOI: 10.1002/QAJ.360
Elliott Graham
{"title":"Development of a professional quality assurance society – the SQA model","authors":"Elliott Graham","doi":"10.1002/QAJ.360","DOIUrl":"https://doi.org/10.1002/QAJ.360","url":null,"abstract":"A snapshot of the Society of Quality Assurance (SQA) entering the 21st century showed declining income and financial reserves, stagnant membership, increasing costs, and frustrated volunteer leadership and administrative management. At the end of the year 2000, the SQA Board of Directors made the bold decision to replace its present management with a new firm that had been formed for the specific purpose of managing the business affairs of SQA, under the leadership of a Quality Assurance (QA) professional with experience and expertise in the management of nonprofit, international professional societies. With that decision made, subsequent SQA Boards seized on numerous opportunities that served to increase income and financial resources, grow membership and membership benefits, hold costs, serve the identified needs, and anticipate the future needs and desires of the leadership and membership of SQA. The changed infrastructure has successfully served to support and nurture the growing and developing needs of QA professionals working in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) regulated environments. Copyright © 2006 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"116 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2006-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115124657","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Ethical dilemmas in research quality assurance 研究质量保证中的伦理困境
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.344
H. Lucas
{"title":"Ethical dilemmas in research quality assurance","authors":"H. Lucas","doi":"10.1002/QAJ.344","DOIUrl":"https://doi.org/10.1002/QAJ.344","url":null,"abstract":"In this essay three examples of ethical dilemmas in research quality assurance are presented. For one of the examples, dealing with the use of placebo control groups in bio-medical research on humans, the balance between ethical and scientific considerations will be evaluated on basis of a critical review of the applicable standards and/or regulations, such as the Declaration of Helsinki and the current Good Clinical Practice (GCP) regulations. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"50 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123304269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality cross‐fertilization 交叉受精应承担的质量
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.353
R. Hattemer‐Apostel
{"title":"Quality cross‐fertilization","authors":"R. Hattemer‐Apostel","doi":"10.1002/QAJ.353","DOIUrl":"https://doi.org/10.1002/QAJ.353","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"69 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134018928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The regulatory and business roles of a Study Director 研究主管的监管和业务角色
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.345
Celeste A. Rose, D. E. Mayer
{"title":"The regulatory and business roles of a Study Director","authors":"Celeste A. Rose, D. E. Mayer","doi":"10.1002/QAJ.345","DOIUrl":"https://doi.org/10.1002/QAJ.345","url":null,"abstract":"The role of Study Director can be a challenging one with technical, administrative, and compliance responsibilities. The Study Director often does not have direct responsibility for personnel and other resources required for his/her studies. In this article, we have attempted to identify traits and mechanisms to help the Study Director do his/her job in a professional and compliant manner. \u0000 \u0000 \u0000 \u0000In addition to regulatory and scientific expertise, Study Director quality attributes include possession of appropriate soft skills and character traits and are key to the success of a study. Study Directors must have an aptitude for effective communication, relationship building, training, mentoring, and delegation. While these soft skills/desirable traits often require additional effort on the part of the Study Director, they have a large impact on the rate of success, efficiency, and compliance of the study overall. \u0000 \u0000 \u0000 \u0000The workshop presented by the authors took a 'hands-on' approach building on the creativity, and experience of Study Directors, supervisors, managers, and Quality Assurance (QA) personnel who participated. The participants deliberated problem scenarios from a Study Director's perspective. The tables and discussion in this article summarize compliant solutions, which arose from the resourcefulness that comes from experience of the participants. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"33 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132496535","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 4
Is it too late for quality 质量问题还来得及吗
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.347
T. Winchell
{"title":"Is it too late for quality","authors":"T. Winchell","doi":"10.1002/QAJ.347","DOIUrl":"https://doi.org/10.1002/QAJ.347","url":null,"abstract":"Quality assurance (QA) is an independent ongoing process that should begin before an operation starts, continue while it is ongoing and after it concludes. While there are some good reasons to conduct QA audits after a clinical research trial has ended, the most cost effective quality measures must be taken prior to study start up with audits conducted early enough in the process to achieve maximum dynamic impact. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130068307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Science and Quality Assurance, part 2: PK/QA 科学与质量保证，第二部分:PK/QA
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.348
Anthony B. Jones
{"title":"Science and Quality Assurance, part 2: PK/QA","authors":"Anthony B. Jones","doi":"10.1002/QAJ.348","DOIUrl":"https://doi.org/10.1002/QAJ.348","url":null,"abstract":"For Quality Assurance to be a proactive partner in drug development we need to understand the scientific concepts that define and shape the pharmaceutical process. Drug development can be more easily understood by considering the basic scientific principles governing the numerous scientific disciplines that contribute to producing safe and effective drugs. This article describes the principles that apply to pharmacokinetics, and how these impact study design and data analysis. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126764120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Implementation of Good Laboratory Practice in a university research unit 良好实验室规范在大学研究单位的实施
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.352
X. Abad, A. Bosch, C. Navarro
{"title":"Implementation of Good Laboratory Practice in a university research unit","authors":"X. Abad, A. Bosch, C. Navarro","doi":"10.1002/QAJ.352","DOIUrl":"https://doi.org/10.1002/QAJ.352","url":null,"abstract":"This article describes our experience in the implementation of Good Laboratory Practice (GLP) in a research group of the Department of Microbiology in the University of Barcelona (UB). Some issues relating to quality assurance in a research laboratory setting are reviewed, and several comments and suggestions arise from our experience in setting up GLP. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"93 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132780240","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 7
International Society of Pharmacovigilance (ISOP) 国际药物警戒学会(ISOP)
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.349
G. Velo, S. Spence
{"title":"International Society of Pharmacovigilance (ISOP)","authors":"G. Velo, S. Spence","doi":"10.1002/QAJ.349","DOIUrl":"https://doi.org/10.1002/QAJ.349","url":null,"abstract":"","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"56 2","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"120990607","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
GIQAR position paper on ‘Archiving and Good Laboratory Practice’† GIQAR关于“存档和良好实验室规范”的立场文件†
Quality Assurance Journal Pub Date : 2005-12-01 DOI: 10.1002/QAJ.346
M. Brunetti, P. Albertini, D. Andreozzi, M. Astolfi, M. Capasso, S. Caroli, E. Corbascio, M. Filippone, E. Invernizzi, R. Lasala, E. Lombardini, G. Malanca, F. Medioli, B. Mónico, Francesco Motta, R. Rizzello, A. Tonnicchi, F. Uberti, R. Valenti, V. Sforza
{"title":"GIQAR position paper on ‘Archiving and Good Laboratory Practice’†","authors":"M. Brunetti, P. Albertini, D. Andreozzi, M. Astolfi, M. Capasso, S. Caroli, E. Corbascio, M. Filippone, E. Invernizzi, R. Lasala, E. Lombardini, G. Malanca, F. Medioli, B. Mónico, Francesco Motta, R. Rizzello, A. Tonnicchi, F. Uberti, R. Valenti, V. Sforza","doi":"10.1002/QAJ.346","DOIUrl":"https://doi.org/10.1002/QAJ.346","url":null,"abstract":"Archiving of documents and specimens generated during a non-clinical laboratory study is a basic Good Laboratory Practice (GLP) requirement. The records and materials that should be archived as well as the characteristics and the organisation of archive facilities are addressed in the OECD Series on Principles of Good Laboratory Practice No. 1 (OECD Principles of Good Laboratory Practice (as revised in 1997) [1]. However, in recent years, questions concerning archiving have been raised and the need for a more detailed guidance on this matter has become evident \u0000 \u0000 \u0000 \u0000The aim of the Society for Applied Pharmacological Sciences/Italian Group of Quality Assurance in Research (SSFA/GIQAR) working group on ‘Archiving according to GLP’ was to issue a position paper, present it for discussion in an ad hoc round table with representatives of the Italian GLP monitoring authority to promote common standards and to provide additional recommendations on storage and retention of records. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121868708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The role and function of quality assurance officers in Ontario hospitals 安大略省医院质量保证官员的作用和职能
Quality Assurance Journal Pub Date : 2005-09-01 DOI: 10.1002/QAJ.335
K. Rondeau, N. Birdi
{"title":"The role and function of quality assurance officers in Ontario hospitals","authors":"K. Rondeau, N. Birdi","doi":"10.1002/QAJ.335","DOIUrl":"https://doi.org/10.1002/QAJ.335","url":null,"abstract":"This article examines the role and job function of quality assurance officers in hospitals in Ontario, Canada. Results from a mail questionnaire suggest that hospital quality assurance professionals in our sample are much more likely to be female, at mid-career, and to have advanced graduate degrees, although most lack professional certification and formal training in quality management. Although the job duties of hospital quality assurance professionals are broad and varied, many report being engaged in traditional quality assurance managerial activities including hospital accreditation efforts, risk management assessment, and patient satisfaction measurement. Coordinating quality assurance activities, performance reporting, and leading the Total Quality Management (TQM)/Continuous Quality Improvement (CQI) initiative remain central functions associated with their work efforts. Nevertheless, limited formal training in the principles and methods of quality management and improvement may be placing significant constraints on their effectiveness. Copyright © 2005 John Wiley & Sons, Ltd.","PeriodicalId":147931,"journal":{"name":"Quality Assurance Journal","volume":"129 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2005-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131367997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 6
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