Master FDA’s New QMSR at Your Own Pace

This self-paced course is designed for regulatory, quality, and compliance professionals who need a clear and practical roadmap to FDA’s new QMSR.

Whether you are updating an existing quality management system or building one from the ground up, this course provides the knowledge and tools to ensure compliance.

This program will help you:

• Master the essentials of 21 CFR 820, ISO 13485, and the latest QMSR requirements.

• Get expert answers to the industry’s most pressing questions about the QMSR transition and what compliance means for your business.

• Receive practical resources to simplify QMSR gap analysis and define Quality System roles.

FDA’s shift from the Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) aligns with ISO 13485, but what does that mean for your compliance strategy?

This on-demand masterclass provides a structured, expert-led approach to understanding and implementing the new QMSR requirements without unnecessary complexity.

• QMSR Fast Facts: Sift through the hype and uncover the hard facts about the new regulation and how it aligns with ISO - and how it doesn't.
• QMSR vs ISO vs MDSAP: Dive deep into each standard to understand how they are similar - and different. We'll talk about differences in definitions and interpretation, as well as what each standard requires for labeling and packaging, reporting and corrections, UDI and signatures.
• Secrets to Success: Get answers to the most frequently asked questions about quality system regulation, plus tips and tricks to help smooth your path to QMSR compliance.