Are you fully prepared for a U.S. Food and Drug Administration inspection? Inspections can be high-stakes events that bring stress, potential delays, and reputational risk if not managed effectively.
This comprehensive, full-day workshop is designed to help quality, regulatory, and research professionals approach inspections with confidence, clarity, and a concrete plan. Moving beyond generic advice, the session delivers a structured, actionable framework—a blueprint for achieving and sustaining inspection readiness. Attendees will learn how to build a proactive inspection strategy, master pre-inspection preparation, assemble and train an effective readiness team, reduce risk, maintain compliance, and navigate inspection day with assurance.
The workshop emphasizes practical, real-world tactics supported by examples and interactive discussions. Attendees will leave equipped with proven tools and a step-by-step approach for transforming a daunting process into a manageable, even strategic, opportunity for operational excellence.
CEUs: 5.5 ACRP
Trainers:
Christina Brennan, MD, MBA, FACRP, Senior Vice President, Clinical Research, Northwell Health
Annie Carter, MBA, CRA, ACRP-CP, Vice President of Research, OneOncology