Are your CAPA investigations closing records or closing problems? Most quality teams know the difference — but far fewer have systems that consistently deliver the latter. In a post-QMSR world where FDA inspectors are no longer satisfied with documented procedures alone, the quality of your investigation thinking is now visible, reviewable, and citable.
This session cuts through the compliance checkbox mentality and focuses on what separates CAPA systems that prevent recurrence from those that generate paperwork. Drawing on direct experience managing CAPA programs for Class III implantable cardiovascular devices across global manufacturing sites under FDA QMSR, Mathangi Srinivasan will walk attendees through the investigation frameworks, root cause methodologies, and systemic thinking approaches that distinguish genuine problem resolution from surface-level corrective action.
Under FDA’s Quality Management System Regulation — effective February 2, 2026 — CAPA is no longer a standalone quality subsystem. It is a dynamic, risk-integrated process connecting design controls, manufacturing operations, supplier quality, and post-market surveillance. FDA inspectors are now reviewing CAPA records not just for closure, but for evidence of systemic risk thinking. This session addresses exactly what that means in practice and how to build CAPA systems that meet that standard.
Attendees will learn:
• How QMSR changed FDA’s expectations for CAPA investigations and what inspectors are actually looking for.
• A structured investigation framework that moves from complaint or nonconformance to verified
systemic root cause
• How to connect CAPA findings to design controls, manufacturing risk, and post-market surveillance, the integration of QMSR demands
• Common failure modes in CAPA systems that generate 483 observations and how to eliminate them.
• How to build effectiveness verification that satisfies FDA’s risk-based review standard
This session is designed for quality engineers, quality managers, regulatory affairs professionals, and operations leaders who manage or contribute to CAPA systems in FDA-regulated environments. Whether you are navigating your first QMSR inspection or rebuilding a CAPA program after enforcement action, you will leave with practical frameworks and investigation tools you can apply immediately.
Presenter Background: Mathangi “Maddy” Srinivasan
Mathangi Srinivasan is a Quality Assurance Manager at Abbott Vascular, where she leads standards engineering and regulatory compliance for Class III implantable vascular devices across global manufacturing sites in California, Costa Rica, Puerto Rico, and Ireland. Her work spans FDA QMSR implementation, ISO 13485 compliance, risk management under ISO 14971, CAPA systems leadership, and post-market surveillance including product recalls and field actions for some of the highest-risk medical devices in clinical use.
Mathangi holds three Master’s degrees in Biochemistry, Manufacturing Systems Engineering, and Business Administration, and is certified as an ASQ Certified Quality Auditor (CQA) and Certified Six Sigma Black Belt (CSSBB). She serves on two AAMI national standards committees : the Vascular Prostheses Committee and the Cardiovascular Absorbable Implants Committee, contributing to the development of safety and performance standards affecting U.S. cardiovascular device manufacturers.
She has published peer-reviewed research and practitioner articles on risk-based quality management and QMSR implementation and recently appeared as a featured expert on the Medical Device Made Easy podcast discussing real-world QMSR implementation challenges facing U.S. manufacturers.