Complaint Handling, CAPA Effectiveness, and Regulatory Updates

Edward Chekan, VP of Medical Affairs and Professional Education at Asensus Surgical, and Humberto Valbuena, Director of Medical Affairs for US and LATAM at Alcon, lead a panel on the interconnected challenges of complaint handling, CAPA effectiveness, and staying current with regulatory updates. Effective complaint handling and CAPA processes are foundational to product safety, yet many organizations struggle to close the loop between customer complaints, root cause analysis, and corrective actions.

The panelists will share best practices for building complaint handling systems that capture meaningful data, CAPA processes that drive real corrective action rather than paperwork, and regulatory monitoring systems that flag relevant changes before they create compliance gaps. Edward and Humberto will draw on their diverse experiences across surgical robotics and ophthalmic devices to illustrate these principles.

Attendees will leave with practical tools and techniques for strengthening the complaint-to-CAPA pipeline and maintaining regulatory currency in a rapidly evolving landscape.