Name
Creating an Audit-Ready Culture: Embedding Regulatory Compliance into Daily Site Operations
Date & Time
Wednesday, October 22, 2025, 1:00 PM - 2:00 PM
Track
Quality / Regulatory
Description
Operationalizing Compliance from Study Start-Up to Close-Out
- Identifying where regulatory risks in clinical research live and methods to help avoid last-minute scrambles
Training Staff for Ownership, Not Just Tasks
- Shifting from checklist compliance to real accountability using onboarding strategies, role-specific expectations, and clear task delineation
Internal QA on a Budget: How to Make Internal Audits Actually Happen
- Prioritizing high-risk areas, keeping audit tools simple and accessible, and creating a feedback loop that improves performance over time
Sustaining Readiness in High-Turnover, High-Volume Environments
- Preventing compliance drift by standardizing tasks, cross-training staff, and documenting institutional knowledge so it doesn’t become person-dependent