This session focuses on how strong day-to-day study practices lead to successful FDA inspections. Using real examples from FDA trends and internal review findings, we will cover common compliance gaps, how to assess and manage protocol deviations, and practical ways to stay audit-ready. Attendees will learn simple, risk-based approaches to documentation, oversight, and self-monitoring, along with how to implement effective CAPAs (corrective and preventive actions) that address root causes.
Zoom link: https://uwmadison.zoom.us/j/91856682838?pwd=qfRq6b7rbYoa1ktQNjQNlRRhrkSDYb.1M/a>
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