SCDM 2025 Annual Conference
Regulations & Standards track
Help! I Have an Upcoming Inspection!” – Regulatory Inspection Best Practices for the Clinical Data Manager
Mon, Sep 29, 2025 · 11:15 AM–12:15 PM EDT Ballroom I-II, Baltimore Convention Center
About this session
Session chaired by Kevin Rutty
Description:
This session will help you be inspection ready, and when an inspection is forth coming - how to prepare for the inspection, how to conduct oneself during the inspection, and how FDA conductions inspections. Will also cover how to be inspection ready for PMDA Inspections and learn about the FDA BIMO Program and debunk some FDA myths.
