DIA 2013 49th Annual Meeting
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Practical Considerations for GCP Audits in a Risk-based Environment
Track
:
Track 11: Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)
Program Code:
115
Date:
Monday, June 24, 2013
Time:
11:00 AM to 12:30 PM
EST
Location:
156AB
CHAIR
:
SPEAKER
(S):
Walter Townsend, (SPKNON), International Director, Quality Assurance, DATATRAK International, Inc., United States
Michael R. Hamrell, PhD,RAC (SPKNON), President, MORIAH Consultants, United States
Liz Wool, BSN,RN (SPKNON), President and Chief Executive Officer, QD-Quality and Training Solutions Inc., United States
Description
A program for audits is an integral means for meeting regulatory expectations for clinical quality. This session will discuss the advent of risk-based approach to monitoring and inspections which means that sponsors should be employing risk-based audits to assess quality.
This session is a part of:
This session is a part of: