Quality Management System Regulation (QMSR) - It's NOT Just ISO 13485!
What you'll gain from this course
This course provides a comprehensive analysis of the Quality Management System Regulation (QMSR) Regulation and its application in regulated industries such as medical devices, pharmaceuticals, biotechnology, and other life sciences sectors. It is designed to equip students and professionals with a thorough understanding of the regulatory frameworks, standards, and best practices that govern the development, implementation, and maintenance of a compliant QMS.
The course focuses on key regulatory and statutory requirements including U.S. FDA 21 CFR Part 820 (Quality System Regulation) and ISO 13485 (Medical Devices – Quality Management Systems). Students will explore the foundational principles of quality management, including customer focus, leadership, process approach, and continuous improvement, and how these principles are embedded within regulatory requirements.
Topics covered include quality system design, risk-based thinking, documentation and record-keeping practices, design control, corrective and preventive actions (CAPA), internal audits, management reviews, supplier quality management, and regulatory inspections. Emphasis is placed on understanding how regulatory bodies assess compliance and how organizations can prepare for inspections and mitigate nonconformities.
Through case studies, industry examples, and practical exercises, students will gain insight into how QMS regulations are applied in real-world settings, from early-stage development to post-market surveillance. The course also highlights failures of effective implementation of key principles that often lead to regulatory citations.
By the end of the course, participants will be able to interpret and apply the QMSR regulatory requirements, support compliance initiatives, and contribute to building a culture of quality within their organizations.
Tutor
This training will be delivered by one of our experts – click here to learn more .
Learning Outcomes
By the end of this training learners will be able to:
- Understand the key areas of the new QMSR
- Learn the meaning of ‘incorporation by reference’ of the ISO 13485 standard
- Clarification of QMSR requirements in addition to those identified by the incorporation by reference of the ISO 13485 standard
- Become aware of terms and definitions used in the QMSR and their origin
- Avoid common errors in interpretation and implementation of requirements
- Better manage external inspections and regulator expectations
- Understand how the new QMSR affects other parts of the Code of Federal Regulations
Who Should Attend
Professionals at all levels of the organization will benefit from this learning including those involved in the design, development, implementation, and oversight of a compliant quality management system
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