Registration
ASQ Salt Lake Section October Webinar
Using Project Management to Drive CAPA in a Medical Device Company
Driving Medical Device Compliance and Quality Through Structured Project Management
Presented by Siavash Ghaffari, CMQ/OE
This month's webinar explores how integrating formal project management principles from the PMI PMBOK Guide can optimize the Corrective Action and Preventive Action (CAPA) process within medical device organizations. Aligned with ISO 13485:2016 and the FDA's Quality Management System Regulation (QMSR), the session will detail how to structure quality improvements using a disciplined, four-phase-gate lifecycle model.
Attendees learn how to strategically evaluate customer complaints, service cases, non-conformance reports (NCRs), and audit findings to determine when formal CAPA escalation is necessary, distinguishing between immediate containment and systemic root-cause investigations.
The framework establishes clear governance through two primary roles: the CAPA Administrator, who oversees phase-gate reviews, and the CAPA Project Manager, who drives investigations, planning, and risk assessments. By moving through structured phases—Proposal, Investigation and Planning, Verification of Activities (VoA) for closure, and Verification of Effectiveness (VoE) for completion—organizations can maintain rigorous traceability, control project scope changes, and ensure that corrective and preventive actions deliver verifiable, long-term compliance.