QMSR Training
Training on the new FDA 21 CFR 820 Quality Management System Regulation for medical devices.
Don’t Risk Non-Compliance! We offer QMSR training courses for the Quality Management System Regulation
The FDA is replacing the long-standing Quality System Regulation (QSR). This new regulation impacts all medical device manufacturers in the U.S. All employees whose work impacts quality will need new training, to replace their old GMP training for medical devices.
We offer GMP training for QMSR, including online leader training, employee training, and LMS compliant training packages (e.g. SCORM).
If you are looking for our training course on QMSR implementation, see our page on QMSR implementation.
What are the Key Changes from QSR to QMSR?
Goodbye to Quality System Regulation. The title for 21 CFR 820 is changed to Quality Management System Regulation (QMSR).
FDA Incorporated by reference ISO 13485:2016 Quality Management System requirements into 21 CFR 820.
The FDA also incorporated by reference ISO 9000:2015 clause 3, Definitions. These are necessary for the application of ISO 13485:2016. The FDA also included additional definitions in the QMSR, as terms and definitions matter to the FDA, and they should matter to you.
The FDA will add new requirements to 21 CFR 820 that will supplement ISO 13485:2016 in order to align with Food, Drug, and Cosmetic Act requirements for medical devices. These include additional requirements for the quality management system, control of records, and labeling and packaging controls. This means that following ISO 13485:2016 alone is insufficient to comply with the new Quality Management System Regulation.
The Current 21 CFR 820 QSR is Going Away!
ISO 13485:2016 is no Longer Voluntary!
ISO 13485:2016 will no longer be a voluntary standard to the U.S. FDA. It will be a regulation that the FDA can and will enforce, including the ISO 13485 requirement for risk management throughout the product lifecycle and quality systems.
3 Options For QMSR Training (GMP Training for Medical Devices)
Choose one of these training options for QMSR, depending on your needs. Group discounts and customization is available. Gain practical advice from a seasoned quality management professional with years of industry experience.
QMSR Training for Employees
Train your employees on the Quality Management System Regulation. Includes key changes from QSR to QMSR. Satisfies annual cGMP training requirement. Suitable for all employees, both new and experienced.
Intended audience:
- Development associates
- Operations associates, including manufacturing, warehouse, facilities, and purchasing
- Quality associates, including document control, inspection and test
- All other employees whose work impacts quality
You’ll get:
- Comprehensive 1-hour online training course
- Interactive quizzes
- Glossary of QMSR terms and definitions for medical device companies
- Certificate of completion
- Expert insights
- 30-day money back guarantee
- Quantity discounts for 3 or more employees
Course Outline
- Welcome to the Course
- Introduction to QMSR
- Terms and Definitions
- ISO 13485 Overview
- ISO 13485 Design and Development
- ISO13485 Production and Service
- Additional Requirements in QMSR
- How QMSR Impacts Employees
- Final Quiz
$129
Note: price is per person
QMSR Training for Leaders
Train your quality professionals and top management on the Quality Management System Regulation. This course focuses more on Top Management responsibilities and topics of interest to experienced quality professionals.
Intended audience:
- Quality leaders
- Quality professionals
- Quality management representatives
- Top management
- Regulatory affairs professionals
You’ll get:
- Comprehensive 45-minute online training
- Interactive quizzes
- US FDA QMSR Final Rule
- ISO 13485:2016
- ISO 9000:2015 definitions section
- Glossary of QMSR terms and definitions for medical device companies
- Certificate of completion
- Expert insights
- 30-day money back guarantee
- Quantity discounts for 3 or more employees
Course Outline
- Welcome to the Course
- Introduction to QMSR
- Terms and Definitions
- ISO 13485 Key Points
- Additional Requirements in QMSR
- How QMSR Impacts Quality Leaders and Top Management
- Final Quiz
$129
Note: price is per person
LMS Compliant QMSR Training for Employees and Leaders
Integrate our QMSR training with your Learning Management System (LMS). SCORM compliant format. We offer both courses: QMSR Training for Employees, and QMSR raining for Leaders in LMS compliant format.
Intended audience
- See intended audience for each of the 2 options.
You’ll get:
- Comprehensive LMS compliant training, tailored to your audience.
- Customization options available. We can modify for your company.
- Compliant SCORM 1.2, SCORM 2004, AICC, Experience API (xAPI), and cmi5
- Interactive quizzes
- Certificate of completion
- US FDA QMSR Final Rule
- ISO 13485:2016
- ISO 9000:2015 definitions section
- Glossary of QMSR terms and definitions for medical device companies
- Expert insights
- Quantity discounts.
- Options for translations in various languages (e.g. French, German, Japanese and Simplified Chinese).
Contact us for pricing
Price based upon number of employees, any customization and languages
Meet The Experts
We are a passionate team with over 40 years of combined experience at dozens of medical device, pharmaceutical and life science companies across the U.S.
Michael Bubien
Michael is a Pharmaceutical / Medical Device consultant with over 20 years of industry experience and extensive knowledge QMSR. He has implemented new quality management systems at multiple companies.
Kathleen Miller
Kathleen is a results-driven consultant with over 20 years experience in Quality Systems & QA. She is an experienced trainer and quality management representative. Kathleen is implementing QMSR for her medical device clients.
