QMSR Implementation Masterclass
This class addresses all of the elements of the 21 CFR 820 changes. The FDA has amended this regulation to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements of ISO 13485:2016. This course aligns regulatory understanding to the framework for the USA with that used by other global regulatory authorities to promote consistency in the regulation of devices and provide a timelier introduction of safe, effective, high-quality devices to patients
At a Glance
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Total Length of Course: 3 hours
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RAC Points: 3
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This course was developed by Michelle Lott and Tianna Benson from LeanRAQA
Learning Objectives
Upon completion of this course, participants should be able to:
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Identify the core requirements of 21 CFR 820, ISO 13485, and the updated Quality Management System Regulation (QMSR).
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Explain the key changes involved in the QMSR transition and how they impact business compliance.
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Describe the tools used for a QMSR gap analysis and the primary roles within a Quality System.
Lesson Titles
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Lesson 1: QMSR Fundamentals
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Lesson 2: Decoding QMSR Expectations
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Lesson 3: QSR vs. ISO 13485 - Comparing Key Process Requirements
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Lesson 4: QMSR vs. ISO 13485 - Key Differences and Definition Hierarchy
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Lesson 5: QMSR Transition
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Lesson 6: Keys to Successful QMSR Transition and Ongoing Compliance
This course is also included in:
