Preparing for an FDA Inspection

Tuesday, December 9, 2025 from 11:00 AM to 12:00 PM

Audits can be stressful. However, being audit ready and prepared can make the process much smoother. Join the UH Office of Research Compliance as they discuss how study teams can be prepared for upcoming inspections from the Food & Drug Administration. By the end of this session, study teams will be able to: Identify the important timepoints and action items in the timeline of an FDA inspection; Describe what study materials are reviewed during an FDA Inspection and how outside Inspectors will access these materials; and Identify common audit findings and how to avoid them as a team.

Presenter: Alycia Slaton, RN, CRCC, Office of Research Compliance Supervisor

CREC: Not Yet Determined

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