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    Demo workspace

    Learning operations/ Training workspaceDemoDRDana ReyesCourse administrator

    Course library

    Available courses

    1 course live for employees — 1 module waiting on your approval before updated videos reach learners.

    MonitoringFederal Register APIFDA.gov / Guidance DocumentsFDA docket RSS feeds

    Quality Management System Compliance

    Core training for RAQA and Quality staff, kept current automatically as regulations change

    1 modules412 enrolledRAQA · Quality · Operations

    1 waiting on you

    • Module 1CAPA Records: Review and ApprovalWaiting on you · FDA QMSR Final RulePending Approval

    Regulatory changes in flight

    What put those modules in the queue. A change never reads further along than its least advanced module.

    Live regulatory change events and the modules each one affects
    ChangeSourceDetectedEffectiveAffectsStage
    FDA QMSR Final Rule21 CFR Part 820 recast as the Quality Management System Regulation, incorporating ISO 13485:2016 by referenceU.S. Food & Drug Administration (FDA)89 FR 7496“Medical Devices; Quality Management System Regulation”Jan 31, 2024Feb 2, 20261 moduleQuality Management System CompliancePending Approval