U.S. Food and Drug Administration (FDA) inspections can be high-stakes events for clinical research sites, especially within large site networks. Yet, many sites and quality assurance (QA) teams only engage reactively, leading to inconsistent readiness and potential regulatory exposure. This session presents a proactive, collaborative model for ongoing alignment between site operations and the network’s QA function. Through real-world examples and practical tools, we’ll demonstrate how early QA involvement, open communication, and joint preparation foster a culture of continuous inspection readiness. Attendees will leave equipped with actionable strategies for collaborative mock audits, risk-based Corrective and Preventive Action (CAPA) plan implementation, and quality-focused training that empowers staff and mitigates FDA risk.

CEU: 1.00 ACRP

Speakers:

• Margaret (Meg) Rood, VP, Operational Excellence, IMA Clinical Research

• Andreja Vlajankov-Salaj, Sr. Director, Quality Assurance, IMA Clinical Research