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FDA QMSR Transition Training for Practitioners and Auditors

4 ★★★★★ 1 Reviews
97% Recommended

FDA QMSR Transition Training is for Quality and Regulatory Professionals who are already familiar with ISO 13485 and FDA’s current Quality System Regulation (QSR) and want to upskill their knowledge of the key differences, implementation impacts and compliance expectations being introduced under the new Quality Management System Regulation (QMSR).

An experienced Instructor will facilitate practical workshops that focus on the real-world implications of the shift from QSR to QMSR offering guided exercises, case studies, examples and group discussions.

Explained: The difference between 16hr FDA QMSR Requirements and 8hr FDA Transition Training

The main difference is that Comply Guru’s 16hr FDA QMSR Requirements training includes additional coverage of ISO 13485 requirements (including similarities and differences vs the QMSR), whereas our 8hr FDA QMSR Transition training is a slimmed down version focusing exclusively on the QSR to QMSR changes.

FDA QMSR Transition Training for Practitioners and Auditors
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
Trusted By Notified Bodies & Global Brands
 
Course Snapshot
Learner Rating
4 ★★★★★ 1 Reviews
Approved By
Comply Guru
Duration
8hrs
Teaching Format
Live Learning
Delivery Options
Virtual or In-Person Workshops
Course Entry Requirements
Prior knowledge is required
Certification on Completion
Issued in 1 business day
Course Content Based on
FDA QMSR
Course Last Updated
November 2025
Language (s)
English
Individual Price
€695.00
Group or In-House Pricing Have 5 or more?

View Sample Certificate of Completion

Upon successful completion, each Learner shall receive a digital Certificate of Completion.
Sample Certificate of FDA QMSR Transition Training for Practitioners and Auditors

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How TÜV SÜD utilized eLearning & saved 40% on Lead Auditor Training

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Zoran Klaric

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Mario Arbesu

VP of Quality Assurance & Regulatory Affairs

How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

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How Comply Guru helped X-Bolt Trauma Orthopedics add real value to their Quality System

“Comply Guru took the stress out of training. Their courses didn’t just tick a box—they added real value to our quality system.”
Bernard Wallace

Bernard Wallace

Quality Affairs Manager

Upcoming Schedule

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Workshop Dates
Daily Schedule
Course Delivery
Location
Fee
Registration
18th - 19th Feb 2026
03:30 PM - 07:30 PM EET
2 x 0.5-days
Virtual Workshops
€695.00
13th - 14th May 2026
03:30 PM - 07:30 PM EEST
2 x 0.5-days
Virtual Workshops
€695.00

Course Overview

FDA QMSR Transition Training

Key Benefits Covered
Accelerated 'Learn By Doing' Methodology
Up-to-date Technical Content & Examples
Practical Case Studies based on Real-World Scenarios
Delivered by Experienced Practitioners with Proven Expertise
Tailored to your Organization
What Will I Learn

On completion of this course, successful Learners will have the practical knowledge needed to:

  1. Explain the rationale behind the FDA’s move from QSR to QMSR
  2. Identify and Analyze the key differences between QSR and QMSR
  3. Understand how ISO 13485 is being integrated into FDA Regulations
  4. Evaluate the impact of QMSR on currently Quality Systems and Documentation
  5. Develop an action plan for transitioning to QMSR
What Are The Entry Criteria

Prior to attending this course, learners are expected to have the following prior knowledge:

FDA QSR 21 CFR Part 820

  • Familiarity with the FDA QSR 21 CFR Part 820 & related requirements.

ISO 13485

  • Familiarity with ISO 13485:2016 requirements.
Who Should Attend
  • Quality Professionals
  • Quality Engineers
  • Regulatory Professionals
Will I Get A Certificate

Successful completion will entitle each Learner to receive a digital Certificate of Completion within 1 business day.

How Will I Be Assessed

In order to successfully complete this course, each Learner will need to:

  • Fully attend the Live Instructor Workshop as 100% attendance is required

Our Methodology

No More Death By PowerPoint

Our courses are designed with practical exercises that have Learners working with scenarios, case studies and material that is focused on a ‘learn by doing’ approach.

No More Death By PowerPoint
No More Death By PowerPoint
 

Course Structure Explained

Detailed Breakdown & Agenda

Attend live, instructor-led workshops emphasizing practical, real-world application.

Time Topic
#1

Introduction and Context

  • FDA’s modernization initiative – Why QMSR
  • Overview of the new rule – Scope and Alignment with ISO 13485
  • Transition timeline and regulatory expectations

Group Discussion “What are you biggest concerns or questions?”
#2

Structural Comparison – QSR vs QMSR

  • Mapping 21 CFR Part 820 to ISO 13485
  • Key similarities and organizational changes
  • Removal of definitions and reliance on ISO
  • Elements retained from QSR in QMSR

Practical Workshop Mapping Exercise
#3

Key Difference in Requirements

  • Risk Management Integration
  • Supplier Control/Purchasing Process
  • Complaint Handling and Reporting
  • Documented Information (Records and Procedures)

Practical Workshop Gap Impact Analysis
#4

Implementation Challenges and Solutions

  • Risk-based  thinking as a core element
  • Updating SOPs and Quality Manual Alignment
  • Supplier evaluation and re-evaluation strategies
  • Internal audit considerations

Practical Workshop QMSR Transition Scenarios
#5

FDA Inspection Readiness under QMSR

  • What to expect in FDA inspections under QMSR
#6

Wrap-Up and Q&A

  • Recap of key takeaways
  • Final Questions

Our Experts

Meet The Instructors

Our experts possess a wealth of industry experience acquired over years of practical application, and in addition, they demonstrate a combination of unwavering passion and a proven aptitude for training.

Michelle Keane

Our Instructor

Michelle Keane

Michelle has a proven track record with over 20 years of experience working across both the Medical Device and Biotechnology sectors. Currently, she is a Lead Auditor for an INAB Accredited Certification Body, and an MDR Assessor for a Notified Body in Europe. In addition, she is the Team PRRC Representative for Ireland.

Watch and Learn More

About our FDA QMSR Transition Training

Learn about the benefits and key features of Comply Guru’s Instructor led Learning.

 
Why Choose Instructor led Learning

Customer Reviews

What Our Learners Are Saying

Read verified reviews from Learners who have completed this course.

Frequently Asked Questions

Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
The fastest and easiest way to pay would be to use your credit card. If you cannot do that, and you require a PO, please email our team at training@complyguru.com
There are recommended requirements for each Learner in wishing to complete any of our eLearning modules. In our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Once you have completed the final assessments, your certificate will be available within 1 business day via your Dashboard. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.

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