DIA 48th Annual Meeting
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The Role of Corrective and Preventive Action (CAPA) in GCP/GLP Audit Quality Management Systems
Track : Track 11: Compliance to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Quality Assurance (QA)
Program Code: 409
Date: Thursday, June 28, 2012
Time: 9:00 AM to 10:30 AM  EST
 Michael Hamrell, MORIAH Consultants, United States
 Michael Hamrell, MORIAH Consultants, United States
 KR Karu, Sparta Systems, United States
 Warren Perry, QUMAS, United States
Corrective and Preventive Action (CAPA) have become an integral part of a GCP Quality Management System approach. A formal program for CAPA is becoming an integral means for meeting FDA and global regulatory expectations for clinical trial quality. The relationship between documentation, deviations and corrective actions is becoming more clear with each 483 letter issued by the FDA. The ability to effectively manage your SOPs, track training and associate them to CAPA resolution is vital.

Learning Objectives:
Recognize CAPA systems can be managed and leveraged to support site inspections
Define clear metrics for the success of GCP/GLP reporting automation
Identify development of effective training programs to deal with issues.