Understanding Risk-Based CAPA Under ICH E6(R3)

Corrective and Preventive Action (CAPA) management is a cornerstone of quality and compliance, but many CROs and site teams struggle to know where to begin. With the recent updates to GCP guidelines, ICH E6(R3), now is the time to ensure your CAPA process is risk-based and inspection-ready. 

This on-demand webinar features a panel of quality management experts, each with valuable insights to share on CAPA best practices. Learn practical strategies for fostering a quality culture in clinical trials under ICH E6(R3). Whether you’re new to CAPA processing or looking to modernize your QMS, this session will help you establish a well-balanced cycle that’s founded on collaboration, traceability, and accountability.

Discussion topics include: 

• What decisions should you make first when planning each stage of the CAPA cycle? 
• How can your quality management system (QMS) scale without becoming buried in investigations? 
• What factors promote “quality by design” while allowing for adequate oversight? 
• How do you become more proactive than reactive regarding training, documentation, and data ownership?