Complimentary Online Quality Management System Regulation (QMSR) Course
Register Now!
Don’t miss this valuable opportunity to enhance your knowledge of quality management systems governing the regenerative medicine technology industry!
- When: Wed, August 27 and Fri, August 29
- Time: 1:00 PM – 4:00 PM
- Location: Online
- Instructor: Rosa Fernandez
- Cost: Complimentary (No cost to attend!)
Course Overview:
This comprehensive online course offers a deep dive into the FDA’s Quality Management System Regulation (QMSR), designed to help professionals in regenerative medicine and related fields understand evolving regulatory expectations. Participants will explore the relationship between QMSR, CGMPs, and ISO standards, and gain practical insights into FDA enforcement, inspection processes, and quality risk management.
Key topics include:
- The role of CGMPs and the FDA in ensuring product quality
- Differences between QMSR and the legacy Quality System Regulation (QSR)
- ISO 9000:2015, ISO 13485:2016, and ISO 14971 compliance
- A 7-step strategy for QMSR implementation
- Implications for medical devices, tissue products, and combination products
Whether you’re preparing for regulatory changes or seeking to strengthen your quality systems, this course provides essential knowledge and actionable strategies to support compliance and innovation.