In both January of 2011 & 2012 at ExL Pharma's first and second Clinical CAPAs Events, Dr. Leslie K. Ball, MD, CAPT, USPHS, Acting Director, Division of Scientific Investigations, Office of Compliance, CDER, FDA participated as the keynote speaker and presented FDA/CDER's expectations for the industry's approach to clinical CAPAs. Her presence and the content she delivered clearly outlined the shift in the FDA's approach for assessing data integrity, which is driving the necessity for the industry to understand, develop and executive corrective and preventive actions in the GCP environment...
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