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Developing a quality management syst...

California State University, Dominguez Hills.

Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles.

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
書名/作者:	Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles.
作者:	Prince, Patricia J.
面頁冊數:	98 p.
附註:	Source: Masters Abstracts International, Volume: 52-01.
Contained By:	Masters Abstracts International52-01(E).
標題:	Business Administration, Management.
ISBN:	9781303227448
摘要、提要註:	The Food and Drug Administration Code of Federal Regulation (FDA CFR) and International Conference of Harmonisation Good Clinical Practices Guidelines (ICH GCP Guidelines) provide the clinical investigator (CI) with the quality standards to follow when conducting clinical trials. The quality standards, however, do not provide CIs with the tools necessary to apply these standards to achieve or sustain quality or to manage compliance issues. It is important for the CI to develop a quality management system (QMS) to ensure proper tools are in place, such as standard operating procedures (SOPs), training, and corrective and preventative action (CAPA) programs, to manage all aspects of the clinical trial at the CI institution. This paper analyzes the FDA CFR, applicable FDA guidance documents, and ICH GCP Guidelines to outline the regulatory requirements and the application of ISO 9001: 2008 (ISO 9001) principles to develop a CI QMS.
電子資源:	http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1523473

Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles.
Prince, Patricia J.

Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles. - 98 p.

Source: Masters Abstracts International, Volume: 52-01.

Thesis (M.S.Q.A.)--California State University, Dominguez Hills, 2013.

The Food and Drug Administration Code of Federal Regulation (FDA CFR) and International Conference of Harmonisation Good Clinical Practices Guidelines (ICH GCP Guidelines) provide the clinical investigator (CI) with the quality standards to follow when conducting clinical trials. The quality standards, however, do not provide CIs with the tools necessary to apply these standards to achieve or sustain quality or to manage compliance issues. It is important for the CI to develop a quality management system (QMS) to ensure proper tools are in place, such as standard operating procedures (SOPs), training, and corrective and preventative action (CAPA) programs, to manage all aspects of the clinical trial at the CI institution. This paper analyzes the FDA CFR, applicable FDA guidance documents, and ICH GCP Guidelines to outline the regulatory requirements and the application of ISO 9001: 2008 (ISO 9001) principles to develop a CI QMS.

ISBN: 9781303227448Subjects--Topical Terms:

423062
Business Administration, Management.

Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles.
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245 1 0 $a Developing a quality management system for a clinical investigator utilizing the ISO 9001 principles.
300 $a 98 p.
500 $a Source: Masters Abstracts International, Volume: 52-01.
500 $a Adviser: William Trappen.
502 $a Thesis (M.S.Q.A.)--California State University, Dominguez Hills, 2013.
520 $a The Food and Drug Administration Code of Federal Regulation (FDA CFR) and International Conference of Harmonisation Good Clinical Practices Guidelines (ICH GCP Guidelines) provide the clinical investigator (CI) with the quality standards to follow when conducting clinical trials. The quality standards, however, do not provide CIs with the tools necessary to apply these standards to achieve or sustain quality or to manage compliance issues. It is important for the CI to develop a quality management system (QMS) to ensure proper tools are in place, such as standard operating procedures (SOPs), training, and corrective and preventative action (CAPA) programs, to manage all aspects of the clinical trial at the CI institution. This paper analyzes the FDA CFR, applicable FDA guidance documents, and ICH GCP Guidelines to outline the regulatory requirements and the application of ISO 9001: 2008 (ISO 9001) principles to develop a CI QMS.
590 $a School code: 0582.
650 4 $a Business Administration, Management. $3 423062
690 $a 0454
710 2 $a California State University, Dominguez Hills. $3 565535
773 0 $t Masters Abstracts International $g 52-01(E).
790 $a 0582
791 $a M.S.Q.A.
792 $a 2013
793 $a English
856 4 0 $u http://pqdd.sinica.edu.tw/twdaoapp/servlet/advanced?query=1523473

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