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