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Practical Considerations for GCP Audits in a Risk-based Environment
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
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.
Learning Objective : Discuss how GCP audit systems can be managed and leveraged to support site inspections; Define clear metrics for the success of GCP reporting; Identify development of risk-based approaches to GCP compliance assessment.
Speaker(s)
Auditing in Today’s Changing Environment
Walter Townsend
DATATRAK International, Inc., United States
Senior Director, Quality Assurance
Conducting GCP Audits Using a Risk-based Model
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
Critical Aspects of CAPA and Root Cause Analysis
Liz Wool, BSN
Wool Consulting Group Inc., United States
President
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