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April Member Webinar

How to Kill a Zombie CAPA

America/Denver
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Ending the Never-Ending Corrective Action with Statistical Thinking
Many quality professionals have encountered the “never-ending CAPA”- corrective actions that remain open for years because organizations believe effectiveness means eliminating all defects. In reality, complex systems rarely reach zero events, and holding CAPAs to that standard often leads to extended investigations, repeated effectiveness checks, and little meaningful improvement.

In this session, Katie will share how statistical thinking and structured trend analysis can break the infinite CAPA cycle. Drawing on real-world case studies from medical device organizations, including work that supported closing a CAPA tied to late regulatory reporting and resolving an FDA Form 483 observation and warning letter, she will demonstrate how organizations can prove CAPA effectiveness through statistically significant improvement and sustainable process controls.

Participants will learn how to:
  • Distinguish between CAPA effectiveness and continuous improvement
  • Apply statistical trend analysis to demonstrate meaningful process improvement
  • Establish governance mechanisms that maintain ongoing monitoring outside of CAPA
  • Defend CAPA closure decisions to auditors and regulators

Attendees will leave with practical strategies to prevent “zombie CAPAs,” close corrective actions confidently, and create sustainable quality improvement systems.


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Katie Swenson headshot

Katie Swenson

Sr. Manager, Device Safety Regulatory Reporting, ICU Medical

Katie is a Quality Leader with more than 15 years of experience in the medical device industry, specializing in quality systems, regulatory reporting, and data-driven process improvement. She has held quality roles across laboratory services, sterilization operations, and medical device manufacturing at organizations across Utah.

She holds a Bachelor of Science in Forensic Science from Weber State University and maintains several certifications from ASQ, including Certified Quality Process Analyst (CQPA), Certified Medical Device Auditor (CMDA), and Certified Quality Engineer (CQE). She is currently pursuing the Certified Manager of Quality/Organizational Excellence (CMQ/OE).

With more than a decade of leadership experience in quality management, Katie is particularly passionate about transformational change within quality systems and helping organizations move beyond reactive compliance toward sustainable, data-driven improvement.