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Papers and Presentations

Upcoming Presentations:

Location and Date Title Presenter
None Scheduled At This Time

Past key papers, presentations, proceedings, and publications are listed below.


White Papers, Commentary and Regulatory Feedback Papers

DQRI Comments to the FDA Regarding 21 CFR Part 11, Docket No. 2004N-0133 (download pdf file)


Past Presentations

Location and Date Title Presenter
DIA Annual Meeting, 2006 Session: A Critical Examination of Database Audits
(content added to database audits page
Kit Howard, DQRI.
DIA Annual Meeting, Washington DC, June 2005 Session: Advancing Data Quality in the 21st Century Kit Howard, DQRI
Presentation: Defining Data Quality: The FDA Perspective Janet Woodcock, FDA (Invited)
Presentation: Defining Data Quality in Medical Practice Paul Miles, American Board of Pediatrics
Presentation: Achieving Data Quality: The Role of DQRI Kaye Fendt, DQRI
West Coast DIA Drug Development Forum, October 2004 Advancing Clinical Data Quality in the 21st Century (download pdf file) Kaye Fendt
Society for Clinical Data Management, Fall Conference, October 2004 Evaluating Risk in Software Validation (download pdf file) Anthony Costello
Standards In the Modern World (download pdf file) Kit Howard
Software Process Improvement Network (SPIN) 2004 The Case for (Clinical) Data Quality (download pdf file) Kay Obenshain
Annual Quality Congress, American Society for Quality, May 2004 Data Quality in the Biomedical Field Sue Carroll
Society for Clinical Trials Annual Meeting, May 2004 Data Quality Strategies in 2004 (download pdf file) Kaye H. Fendt
A Standard Vocabulary for Risk Assessment Don Hopkins
FDA Discussant Comments (download pdf file) Steve Wilson
Society for Clinical Data Management Spring Forum, March 2004 A Model for Software Validation (download pdf file) Anthony Costello


Past Proceedings

Location and Date Title Author
13th International Conference on Software Quality, October 2003 The Case for (Clinical) Data Quality Sue Carroll and Kaye H. Fendt
Annual Quality Congress, American Society for Quality, May 2004 Data Quality in the Biomedical Field Sue Carroll


Publications

Location and Date Title Author
DataBasics, Summer 2004 The Case for Clinical Data Quality (download pdf file) Kaye H. Fendt
DataBasics, Fall 2004 What is DQRI (download pdf file) Kit Howard
A Model for Software Validation (download pdf file) Anthony Costello


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