Quality Management System Regulation (QMSR) – It’s NOT Just ISO 13485!

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.

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

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

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices. She has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.