T4E Organizational Solutions for Implementing Effective Corrective Action and Prevention Plans (CAPA) Following Internal Quality Assurance Compliance Reviews

Subject Area: Auditing and Monitoring 

Knowledge Level: Intermediate

• Review risk-based quality assurance, audit scope, and methodology
• Describe the use and benefits of internal monitoring and avenues to engage institutional leaders
• Discuss strategies for evaluating the organizational effectiveness of corrective action planning

Natalie Ramello, Vice President Chief Institutional Compliance Officer, UT Southwestern

Deepika Bhatia, Director -Research & Academics Compliance, UT Southwestern Medical Center