BEGIN:VCALENDAR VERSION:2.0 PRODID:-//PYVOBJECT//NONSGML Version 1//EN BEGIN:VTIMEZONE TZID:America/Denver BEGIN:STANDARD DTSTART:20001029T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYMONTH=10;UNTIL=20061029T080000Z TZNAME:MST TZOFFSETFROM:-0600 TZOFFSETTO:-0700 END:STANDARD BEGIN:STANDARD DTSTART:20071104T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=11 TZNAME:MST TZOFFSETFROM:-0600 TZOFFSETTO:-0700 END:STANDARD BEGIN:DAYLIGHT DTSTART:20000402T020000 RRULE:FREQ=YEARLY;BYDAY=1SU;BYMONTH=4;UNTIL=20060402T090000Z TZNAME:MDT TZOFFSETFROM:-0700 TZOFFSETTO:-0600 END:DAYLIGHT BEGIN:DAYLIGHT DTSTART:20070311T020000 RRULE:FREQ=YEARLY;BYDAY=2SU;BYMONTH=3 TZNAME:MDT TZOFFSETFROM:-0700 TZOFFSETTO:-0600 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT UID:20260430T093656Z - 19299@am534a.odoo.com DTSTART;TZID=America/Denver:20260416T180000 DTEND;TZID=America/Denver:20260416T191500 CREATED:20260430T093656Z DESCRIPTION:April Member Webinar\nEnding the Never-Ending Corr ective Action with Statistical Thinking Many quality professionals have en countered the “never-ending CAPA”- corrective actions that remain open for years because organizations believe effectiveness means eliminating a ll defects. In reality\, complex systems rarely reach zero events\, and ho lding CAPAs to that standard often leads to extended investigations\, repe ated effectiveness checks\, and little meaningful improvement. In this ses sion\, Katie will share how statistical thinking and structured trend anal ysis 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 ob servation 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 improvementApply statistical tre nd analysis to demonstrate meaningful process improvementEstablish governa nce mechanisms that maintain ongoing monitoring outside of CAPADefend CAPA closure decisions to auditors and regulators Attendees will leave with pr actical strategies to prevent “zombie CAPAs\,” close corrective action s confidently\, and create sustainable quality improvement systems. If you 're looking to join late\, click below to join the Webinar directly. ​ Join Webinar Katie Swenson Sr. Manager\, Device Safety Regulat ory Reporting\, ICU Medical Katie is a Quality Leader with more than 15 ye ars 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 operati ons\, and medical device manufacturing at [...] DTSTAMP:20260430T093656Z SUMMARY:April Member Webinar X-ALT-DESC;FMTTYPE=text/html:April Member Webinar\nEnding the Never-Ending Corrective Action with Statistical Thinking Many quality prof essionals have encountered the “never-ending CAPA”- corrective actions that remain open for years because organizations believe effectiveness me ans eliminating all defects. In reality\, complex systems rarely reach zer o events\, and holding CAPAs to that standard often leads to extended inve stigations\, repeated effectiveness checks\, and little meaningful improve ment. In this session\, Katie will share how statistical thinking and stru ctured trend analysis can break the infinite CAPA cycle. Drawing on real-w orld case studies from medical device organizations\, including work that supported closing a CAPA tied to late regulatory reporting and resolving a n FDA Form 483 observation and warning letter\, she will demonstrate how o rganizations can prove CAPA effectiveness through statistically significan t improvement and sustainable process controls. Participants will learn ho w to:Distinguish between CAPA effectiveness and continuous improvementAppl y statistical trend analysis to demonstrate meaningful process improvement Establish governance mechanisms that maintain ongoing monitoring outside o f CAPADefend CAPA closure decisions to auditors and regulators Attendees w ill leave with practical strategies to prevent “zombie CAPAs\,” close corrective actions confidently\, and create sustainable quality improvemen t systems. If you're looking to join late\, click below to join the Webina r directly. ​Join Webinar 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\, speciali zing in quality systems\, regulatory reporting\, and data-driven process i mprovement. She has held quality roles across laboratory services\, steril ization operations\, and medical device manufacturing at [...] END:VEVENT END:VCALENDAR