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Audit Preparedness

FDA/EMA Inspection

The YCCI resources and support are designed to help support and reduce the regulatory and reporting burden on investigators and teams before, during, and after inspections. If you have been notified of the potential of an inspection by a research sponsor or given notice of a pending inspection by Food and Drug Administration (FDA), European Medicines Agency (EMA), or other regulatory agencies notify the YCCI immediately.

YCCI has hosted a number of training sessions which have provided an overview of the FDA inspection process, including internal support as well as a review of case studies related to inspections. For more information on past and future training, visit the Clinical Research Training section of the Education, Training, and Career Development site.

Quality Assurance Contact

Nancy S. Shelton, M.B.E.C., CCRP, CHRC, Senior Associate Director, Clinical Research Quality Assurance and Research Regulatory Initiatives