Repeat audit and inspection findings often persist because Corrective and Preventive Action (CAPA) plans are written to close findings and not to solve the underlying process failures. This session will provide a practical framework for strengthening CAPA in clinical research using real-world case studies, root cause analysis methods, and effectiveness check strategies aligned to current regulatory expectations.

Attendees will examine common CAPA breakdowns, distinguish corrective from preventive actions, and learn how to build action plans that are specific, measurable, sustainable, and more likely to prevent recurrence. Through interactive discussion and applied examples, attendees will leave with practical approaches they can use to improve inspection readiness, strengthen quality systems, and reduce repeat findings across site and study operations.

CEU: 1.0 ACRP

Speaker:

• Pamela Gonzalez, Education & Research Director, Huron