Understanding of FDA 21 CFR Part 820 - Quality Management System Regulation (QMSR)

Master the new FDA 21 CFR Part 820 – Quality Management System Regulation (QMSR) 

Stay ahead of regulatory changes with our in-depth training on FDA 21 CFR Part 820 – Quality Management System Regulation (QMSR). This course is designed to equip medical device professionals with the knowledge and tools needed to comply with the FDA’s updated QMSR, aligned with ISO 13485.

Key Features of This Training:

• Comprehensive overview of FDA 21 CFR Part 820 and the transition from QSR to QMSR

• Detailed comparison between QSR and ISO 13485 requirements

• Real-world application tips and compliance best practices

• Expert guidance 

• Interactive Q&A and access to supporting materials

Benefits of Attending:

• Understand the FDA’s latest expectations for quality management systems

• Identify and close gaps between your current QMS and QMSR requirements

• Enhance internal audit and inspection readiness

• Minimize compliance risk and avoid costly enforcement actions

• Improve cross-functional collaboration in quality and regulatory compliance

Who Should Attend:

• Quality Assurance & Regulatory Affairs professionals

• Medical Device Manufacturers and Suppliers

• Quality System Managers & Auditors

• R&D and Engineering teams involved in compliance

Conclusion:

Whether you're preparing for the QMSR transition or strengthening your existing quality system, this training will provide the clarity and confidence you need to ensure compliance. Don’t miss this opportunity to build a robust and FDA-aligned Quality Management System.

Enroll now to stay compliant, competitive, and audit-ready with the latest FDA QMSR knowledge!