Through a series of lectures, interactive discussions and case studies, this course provides in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. The course emphasizes using the principles of the medical device quality system (QS) regulations and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today's dynamic regulatory environment. You will learn about key processes in the quality system medical device regulation (21 CFR 820) and ISO 13485, while learning how to address noncompliance challenges from a practical standpoint. The instructor provides insight into implementing an effective CAPA system and using it as an improvement tool. The course also discusses current industry trends, FDA initiatives, best practices for interacting with regulatory agencies, and a brief overview of the FDA Quality System Inspection Technique (QSIT) and Medical Device Single Audit (MDSAP) programs.

Learning Outcomes

At the conclusion of the course, you should be able to

• Demonstrate how the "GXPs" interrelate with each other throughout the product life-cycle.
• Understand the underlying concepts and principles of the FDA QSR and ISO 13485:2016
• Update on how global initiatives are impacting the regulatory environment
• Understand how the MDSAP (Medical Device Single Audit Program) is impacting global regulatory inspections
• Identify and discuss non-compliances to the FDA QSR and ISO 13485:2016 through case studies
• Conduct a critical analysis of a “real life” company and present findings to the class
• Learn how to use the quality system as a tool to achieve strategic business objectives

Topics Include

• "GXPs" and how they relate to each other
• The FDA QS Regulation vs. ISO 13485, including updates to ISO 13485:2016
• Regulatory intelligence resources
• How to use principles of the FDA Quality System Regulation to critically analyze a real-world company
• How to prepare and host regulatory inspections and use the quality system as a tool to achieve strategic business objectives

Working knowledge of:

• Google Workspace or Microsoft Office to submit assignments
• Canvas navigation links, modules, and using the inbox to communicate with the instructor

Additional Information

Please review section notes to view the full schedule.

This course was formerly titled "Medical Device Quality Systems" & "Quality Systems for Medical Devices: FDA QSR and ISO 13485"