Free webinar: The new FDA Quality Management System Regulation (QMSR)
The long-awaited final rule has been published. In this webinar you will learn about the harmonization effort by FDA versus the ISO 13845:2016 and the “incorporation by reference” approach
Outcome
The long-awaited new version of the FDA's Quality System Regulation (QSR) has finally been published. Manufacturers will have until Feb. 2, 2026 to align their quality system with the Quality Management System Regulation (QMSR), which is heavily based on ISO 13485:2016. This free webinar will present the key changes.
Who should attend
This webinar is intended for anyone who has responsibility for one or more elements of an organization’s quality management system, including staff and top management in regulatory compliance, Quality Assurance, and internal auditing.
Speaker
Enzo Passalia, DONAWA LIFESCIENCE CONSULTING Srl
