cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation Training

Days: 0.5 • CEU Hours: 0.4

7:30 AM – 11:30 AM MST

Overview

The 2024 revision of FDA 21 CFR Part 820 marks a major shift in medical device quality system requirements, aligning more closely with ISO 13485:2016 through the new Quality Management System Regulation (QMSR). Understanding these changes is essential for maintaining compliance and avoiding costly delays as the 2026 enforcement deadline approaches.

QMSR applies to all FDA-regulated medical device manufacturers and introduces key updates that impact quality planning, documentation, audits, and risk management. It also reinforces the role of programs like MDSAP in supporting FDA compliance efforts.

This focused, half-day, live-online FDA 21 CFR Part 820 training delivers exactly what busy professionals need: a clear, practical overview of the new requirements and what they mean for your organization. You’ll learn what’s changing, what’s staying, and how to begin planning your transition immediately—with real examples and actionable guidance you can apply the same day. Whether you’re in quality, regulatory affairs, or executive leadership, this course will help you stay compliant, reduce risk, and move forward with confidence.

What You’ll Learn

The FDA’s announcement on February 2, 2024 to integrate ISO 13485:2016 into the new FDA 21 CFR 820 QMSR
New implementation timeline
Real examples of what’s new, and what is being removed or becoming obsolete
Examples of what is still required by FDA regulations until February 2026
The importance of getting started RIGHT NOW to create the Quality Manual, etc.
Medical Device Single Audit Model (MDSAP) and how impactful it can be to the QMS and audit program

ISO 9001 Revision & IA9001 Early Transition Training - Engineer Testing System

Who Should Attend

ALL companies who make a medical device regulated by the FDA (Class I, II and III)
Top/Senior Management – Strategic Planners
Regulatory Management – Strategic and Tactical Planners
Regulatory Associates – Tactical – “Doers” of the work
Marketing Management – Strategic Planners and Post-Market Surveillance
Quality Managers and Associates
Auditors: Internal & 3rd Party external auditors
Consultants advising clients on making the upgrades to the new QMSR
Design and Development Engineers and Management
Product Risk Managers

FDA 21 CFR Part 820 QMSR Implementation Training Objectives

Understand the primary changes from QSR to the QMSR
Understand the importance of creating a Quality Plan to effectively plan for the changes
Identify the necessary steps as to prepare an organization to transition to the QMSR requirement
Understand the importance of MDSAP for your organization

Agenda

Part 1: High-level overview of the planned QMSR changes

Part 2: In-depth review of the planned QMSR changes

Part 3: Implementation timeline

Part 4: Strategy for deployment so the company’s QMS complies to the new QMSR regulation

Part 5: The importance of MDSAP

Part 6: Connecting with the appropriate Notified Body or Certification Body

Course Certificate

Participants will receive a cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation training certificate.

Related Courses


ISO 13485 Lead Auditor Training – Recognized by Exemplar Global	Medical Device Single Audit Program (MDSAP) Training – Recognized by Exemplar Global	ISO 13485 Internal Auditor Training – Recognized by Exemplar Global	CAPA & Root Cause Investigation for Medical Device & Pharmaceuticals Training

Date/Registration

cGMP 2024 Revision: FDA 21 CFR Part 820 QMSR Implementation — $595