IMPLEMENTING FDA QMSR

Service Description

This half-day training session provides a comprehensive overview of the new Quality System Management Review (QSMR) requirements going into effect in February 2026. Participants learn what has changed, why the update is being implemented, and how to integrate the updated QSMR expectations into their Quality Management System (QMS). The session covers: Key changes in the 2026 QSMR update, including expanded inputs, enhanced data trending requirements, strengthened outputs, and mandatory cross-functional participation. How to operationalize the updated QSMR, with guidance on workflows, documentation, analytics, and alignment with ISO 9001, ISO 13485, ICH Q10, and FDA expectations. A hands-on case study, where participants apply the 2026 QSMR model to real-world biologics manufacturing scenarios to identify issues, analyze trends, and produce compliant management review outputs. An implementation roadmap, outlining the steps needed to transition to the 2026 model, including QMS updates, data readiness, system upgrades, and competency training. Participants leave with practical templates, checklists, and tools to support seamless adoption of the updated QSMR requirements and ensure organizational readiness ahead of the February 2026 deadline. Date: FEBRUARY 24th, 2026