FDA QMSR Transition Training for Practitioners and Auditors

Name: No More Death By PowerPoint
Uploaded: 2025-04-07T12:08:10+00:00
Duration: 87.6667
Description: 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.

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).

This course empowers teams to transition smoothly and prepare confidently for FDA inspections under the new rule.

This practical 1-day workshop-based course focuses on the real-world implications of the shift from QSR to QMSR offering guided exercises, group discussions, and instructor-led sessions.

FDA QMSR Transition Training for Practitioners and Auditors

Trusted By Notified Bodies & Global Brands

Course Snapshot

Approved By

Comply Guru

Duration

7hrs

Teaching Format

Virtual or In-Person Learning

Certification on Completion

Yes

Language (s)

English

Individual Price

Request Quote

View Sample Certificate of Completion

Upon successful completion, each Learner shall receive a digital Certificate of Completion.

Have 5 or more that need training?

We offer group discounts and are available for in-house (live or virtual) or tailored training in multiple formats.

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Manager Regional Training & Onboarding

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.

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.

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.

Course Overview

FDA QMSR Transition

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:

Explain the rationale behind the FDA’s move from QSR to QMSR
Identify and Analyze the key differences between QSR and QMSR
Understand how ISO 13485 is being integrated into FDA Regulations
Evaluate the impact of QMSR on currently Quality Systems and Documentation
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

Familiarity with the FDA QSR.

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

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

Frequently Asked Questions

Do we offer in-house / private training?

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.

What is the maximum number of learners in the live workshops?

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.

What payment methods do we accept?

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

What technology is used for this training?

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.

When and where do I get my course certificate?

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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