Event
Workshop
Good Clinical Practice: Workshop 2 - Surviving a Research Audit
Date:
Tuesday, September 30, 2025
Time:
4:00 pm - 5:30 pm
Location:
Zoom
Cost:
Free
Presenter:
Richard J. Karalus, PhD - Director of Research Compliance, Office of Research Compliance, University at Buffalo
Sponsor:
UB Clinical and Translational Science Institute Workforce Development Core
The Food and Drug Administration (FDA) conducts clinical investigator inspections to determine whether clinical studies are being conducted in compliance with applicable requirements. These investigations can be held with or without prior notice, therefore an investigator must always be prepared for an audit.
This workshop provides an overview of what the FDA requires during an investigator audit.
Links
For more information, contact:
Catherine Sedota
Email: cmp9@buffalo.edu
Phone: 716-844-9282
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