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.

This focused online training provides a clear and practical understanding of the QMSR framework, including its structure, regulatory intent and inspection implications.

The course explains how QMSR affects design controls, supplier management, risk-based processes and quality documentation while clarifying the connection between ISO 13485 clauses and FDA-specific expectations.

The session is intended for organizations preparing for the transition and teams that require structured training and documented competency for audit purposes.

Course Details

Date: 14.12.2026
Hours: 09:30–13:00
Format: Online

What You Will Learn

• 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

Who Should Attend?

Professionals working in the medical device industry, including:

• Quality and Regulatory
• R&D and Engineering
• Manufacturing
• Clinical teams

Prerequisites

• No prior knowledge is required. However, familiarity with ISO 13485 and ISO 14971 is a significant advantage, as it will deepen participants’ understanding and improve their engagement with the training content.
• Participants who are unfamiliar with these standards may complete supplementary learning after the course to strengthen their knowledge and gain the full benefit of the QMSR transition training.