Quality assurance (San Diego, Calif.)最新文献_第5页

Does your clinical investigator understand the consequences of non-compliance? 你的临床调查员了解不遵守规定的后果吗?

Quality assurance (San Diego, Calif.) Pub Date : 1999-07-01 DOI: 10.1080/105294100750035116

B J Donato, T R Gibson

引用次数: 4

A comparison of the U.S. EPA FIFRA GLP standards with the U.S. FDA GLP standards for nonclinical laboratory studies. 美国EPA FIFRA GLP标准与美国FDA GLP标准在非临床实验室研究中的比较。

Quality assurance (San Diego, Calif.) Pub Date : 1999-07-01 DOI: 10.1080/105294100750035125

K L Keatley

引用次数: 5

A comparison of the U.S. FIFRA GLP standards with the Japan MAFF GLP standards. 美国FIFRA GLP标准与日本MAFF GLP标准的比较。

Quality assurance (San Diego, Calif.) Pub Date : 1999-07-01 DOI: 10.1080/105294100750035134

J Borchert

引用次数: 0

Confronting actual practice with practice guidelines in oncology. 面对肿瘤学实践指南的实际实践。

Quality assurance (San Diego, Calif.) Pub Date : 1999-07-01 DOI: 10.1080/105294100750035143

S Hoelzer, S A Hundahl, A Stewart, C Reiners, R Liu, R Schweiger, J Dudeck

引用次数: 7

EPA's state of affairs for the GLP program fiscal year 1998. 环保署1998财政年度GLP计划的情况。

Quality assurance (San Diego, Calif.) Pub Date : 1999-04-01 DOI: 10.1080/10529410050133862

F E Liem, R L Cypher, M J Lehr

引用次数: 0

Information resources on quality available on the Internet. 互联网上可获得的高质量信息资源。

Quality assurance (San Diego, Calif.) Pub Date : 1999-04-01 DOI: 10.1080/10529410050133853

R Dewoskin

引用次数: 0

A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions. 美国环保署和FDA对电子记录、电子签名和电子提交要求的审查。

Quality assurance (San Diego, Calif.) Pub Date : 1999-04-01 DOI: 10.1080/10529410050133844

K L Keatley

{"title":"A review of US EPA and FDA requirements for electronic records, electronic signatures, and electronic submissions.","authors":"K L Keatley","doi":"10.1080/10529410050133844","DOIUrl":"https://doi.org/10.1080/10529410050133844","url":null,"abstract":"Both the United States Environmental Protection Agency (EPA) and the U.S. Food and Drug Administration (FDA) have issued regulatory documents that address the issues and requirements concerning electronic reporting to the Agencies. EPA has published two comprehensive and useful electronic data interchange (EDI) guidelines: 1) the EPA Electronic Data Interchange (EDI) Implementation Guideline, Draft of September 23, 1994 and October 18, 1994 that is available at the following EPA web site address: www.epa.gov/oppeedi1/guidelines/general.pdf and 2) the Interim Final Notice, Filing of Electronic Reports via Electronic Data Interchange, September 4, 1996, Federal Register Notice [FRL-5601-4, Volume 61, Number 172, page 46684], also available at: www.epa.gov/oppeedi1/edipoli.htm. The FDA has published a guidance document titled, \"Guidance for Industry, Computerized Systems Used in Clinical Trials, April 1999\" that is available at FDA's web site: www.fda.gov/ora/compliance_ref/bimo/ffinalcct.++ +htm. FDA's guidance document addresses a number of issues for electronic records that are applicable to all areas of GLP compliance. Another FDA document presently under development is titled, \"Electronic Standards for the Transmission of Regulatory Information (ESTRI) Gateway.\" The ESTRI document defines strategic plans for electronic submissions to FDA. FDA has published a guidance document in this area titled, \"Guidance for Industry: Providing Regulatory Submissions in Electronic Format--General Considerations, January 1999.\" This guidance document is available at: www.fda.gov/cder/guidance/index.htm. FDA has also published an important final rule applicable to all electronic records and signatures that is part of the U.S. Title 21 Code of Federal Regulations (CFR), Part 11, titled, \"FDA's Final Rule, Electronic Records; Electronic Signatures, effective August 20, 1997.\" This FDA ruling is discussed below and is available at: www.fda.gov/cder/esig/index.htm.","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 2","pages":"77-89"},"PeriodicalIF":0.0,"publicationDate":"1999-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/10529410050133844","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21826777","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: 9

Quality beyond compliance. 质量超越合规。

Quality assurance (San Diego, Calif.) Pub Date : 1999-01-01 DOI: 10.1080/105294100277705

N Centanni, M Monroe, L White, R Larson

{"title":"Quality beyond compliance.","authors":"N Centanni, M Monroe, L White, R Larson","doi":"10.1080/105294100277705","DOIUrl":"https://doi.org/10.1080/105294100277705","url":null,"abstract":"The service sector within the biopharmaceutical industry has experienced phenomenal growth over the past decade. In the highly regulated Good Laboratory Practices environment, the need for timely, high-quality service, accurate results, and on-time deliverables becomes paramount for the success and profitability of biopharmaceutical companies. The quality assurance process is a vital component of this drug product-development cycle and ensures compliance to the highest domestic and international regulatory standards. Quality-assurance professionals historically have held the role of independent auditors of the processes, who certify that results meet current standards of practice. Covance, a contract research organization that includes Good Laboratory Practices laboratories, reorganized and expanded the functional responsibilities of its quality assurance team in 1997. Auditors and quality assurance professionals have assumed roles beyond traditional compliance auditing and are forging new leadership and mentoring roles as process-improvement specialists. The results have been tangible, measurable benefits for clients and the Covance organization. This article provides an overview of this cultural change and the processes put in place to improve efficiency, productivity, and customer and employee satisfaction.","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 1","pages":"17-35"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294100277705","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21559910","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

History of the Korean GLPs and the activities and perspectives of the Korean Society of GLP. 韩国GLP的历史和韩国GLP协会的活动和观点。

Quality assurance (San Diego, Calif.) Pub Date : 1999-01-01 DOI: 10.1080/105294100277732

I J Yu, Y H Chung, S H Maeng, K S Song, Y M Lee, H K Chung, H J Kim, J I Park, S K Lee, Y H Lee, J S Chang

{"title":"History of the Korean GLPs and the activities and perspectives of the Korean Society of GLP.","authors":"I J Yu, Y H Chung, S H Maeng, K S Song, Y M Lee, H K Chung, H J Kim, J I Park, S K Lee, Y H Lee, J S Chang","doi":"10.1080/105294100277732","DOIUrl":"https://doi.org/10.1080/105294100277732","url":null,"abstract":"The Korean Society of Good Laboratory Practice (KSGLP) was established Dec. 10, 1998. The objectives of the KSGLP are to enhance the quality of domestic studies and the level of GLP compliance, in safety testing, and to promote information exchange among its members. The activities of KSGLP include: offering workshops and symposiums, linking with related governmental organizations, collecting GLP related information and providing the information to the related organizations, building international networks to collect information and to establish relationship, developing training materials and publishing periodicals, and other business necessary to achieve the objectives of the KSGLP. The KSGLP achieved its goals within a short period of time by offering workshops and symposia, and by providing important GLP related information in newspapers or via the KSGLP's internet homepage (www.ksglp.or.kr). The main role of the KSGLP will be to disseminate GLP technology nationwide. The KSGLP would like to help many labs that are preparing their facilities for GLP compliance. Further, the KSGLP is hoping to share GLP experiences with other members.","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 1","pages":"57-62"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294100277732","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21560511","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

Quality through metrics. 通过度量实现质量。

Quality assurance (San Diego, Calif.) Pub Date : 1999-01-01 DOI: 10.1080/105294100277697

L Frederick, T Kallal, H Krook

{"title":"Quality through metrics.","authors":"L Frederick, T Kallal, H Krook","doi":"10.1080/105294100277697","DOIUrl":"https://doi.org/10.1080/105294100277697","url":null,"abstract":"The Quality Assurance Unit analyzed 18 months of departmental data regarding the report-audit cycle. Process mapping was utilized to identify milestones in the cycle for measurement. Five milestones were identified in the audit cycle, as follows: (1) time from report receipt in quality assurance to start of audit, (2) total calendar days to audit a report, (3) actual person-hours to perform a report audit, (4) time from completion of audit to issuance of report, and (5) total time a report is in quality assurance. An interrelationship diagraph is a quality tool that is used to identify what activities impact the overall report-auditing process. Once the data collection procedure is defined, a spreadsheet is constructed that captures the data. The resulting information is presented in time charts and bar graphs to visually aid in interpretation and analysis. Using these quality tools and statistical analyses, the Quality Assurance Unit identified areas needing improvement and confirmed or dispelled previous assumptions regarding the report-auditing process. By mapping, measuring, analyzing, and displaying the data, the overall process was examined critically. This resulted in the identification of areas needing improvement and a greater understanding of the report-audit cycle. A further benefit from our increased knowledge was the ability to explain our findings objectively to our client groups. This sharing of information gave impetus to our clients to examine their report-generation process and to make improvements.","PeriodicalId":77339,"journal":{"name":"Quality assurance (San Diego, Calif.)","volume":"7 1","pages":"5-16"},"PeriodicalIF":0.0,"publicationDate":"1999-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/105294100277697","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"21559909","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