FDA QSR to QMSR Transition Training – Online

QMSR Transition Training: Adapting to the New FDA Regulation

The FDA’s new Quality Management System Regulation - QMSR - has officially replaced 21 CFR Part 820 and incorporates ISO 13485:2016 by reference.

For organizations that have not yet fully prepared, or for teams that require structured training and documented competency for audit purposes, this session is essential.

This focused online training provides a clear and practical understanding of the QMSR framework - its structure, regulatory intent, and inspection implications. The course addresses how QMSR affects core QMS elements such as design controls, supplier management, risk-based processes, and quality documentation, while clarifying the interface between ISO 13485 clauses and FDA-specific expectations.

By the end of the session, participants will be able to:

• Understand the regulatory implications of the QMSR final rule

• Conduct a structured gap assessment between legacy QSR practices and QMSR requirements

• Identify required updates to SOPs, forms, and quality documentation

• Strengthen risk-based integration across the QMS

• Prepare for FDA inspections under the QMSR framework

• Demonstrate formal training and competency during audits

When?     14.12.2026

Location: Online

Instructor: Dr. Sivan Louder

Who Should Attend

Professionals working in the medical device industry, including Quality, Regulatory ,R&D, Manufacturing, Engineering, and Clinical teams.