Certified Bio Medical Auditor

    Course objectives

    By the end of TransformEd’s training in Certified Bio Medical Auditor, you will be able to:

    Benefits for Individuals:
    • Analyze the effectiveness of a biomedical quality management system in relation to those national and international regulations.
    • Apply quality tools and process improvement techniques using qualitative and quantitative.
    • Appropriate standard driven data analysis and statistical techniques used for sampling.
    • Create an effective audit report, apply record retention requirements, and know when an audit can be closed.
    • Document observations, collect objective evidence, use working papers, and classify nonconformance.
    • Distinguish between audit procedural references and guidance’s (such as ISO 19011 and GHTF SG4) and the FDA Quality System Inspection Technique (QSIT).
    • Identify and apply standards related to risk management and hazard detection.
    • Identify and apply standards related to methods ofï sterilization for aseptically processed and terminally sterilized products.

    Key features:

    • Instructor led Classroom Training
    • Copy of study materials
    • Internationally recognized course content.
    • Course Completion Certificate

    Eligibility:

    • Biomedical/Pharmaceutical, Quality Manager, Medical Officers, Lab Technician, Pharmacist
    • Associate degree - one year waived
    • Bachelor’s degree - three years waived
    • Master’s or doctorate - four years waived

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