Managing FDA Inspections

About this session

An FDA inspection is a stressful event even for a well-run site or sponsor, and preparation done during the notification window is preparation done too late. This session covers the full inspection lifecycle with practical, experience-based guidance. We'll address readiness: document organization and retrievability, staff training on interview conduct, the front room and back room model, and mock inspection programs that surface problems while there's still time to fix them. We'll walk through inspection-day management — hosting, scribing, document control, and how to answer questions accurately without volunteering unnecessary scope. Finally, we'll cover the close-out and response phase, including how to read a Form FDA 483, structure a credible corrective action response, and address root cause rather than symptom.

Takeaways

Establish inspection readiness practices that function continuously, not reactively

Manage inspection-day logistics, staff conduct, and document flow effectively

Draft 483 responses that address root cause and withstand follow-up scrutiny

Speakers

• MV

  Megan Vaz

  Operational GROwth Admin · ClinGRO Solutions | Coffee To GRO

  Speaker

• HK

  Heather Kim

  IRB, QA Manager · WCG

  Speaker