2017-2018 Academic Catalog 
    
    Mar 29, 2024  
2017-2018 Academic Catalog [ARCHIVED CATALOG]

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MEDDV 105 - Quality Auditing for Medical Devices



3.0 Credits
Principles/techniques for assessing quality systems for medical device manufacturers. Includes evaluating the quality system as it conforms to FDA regulatory requirements, standards; audit terms, types and concepts; methods for planning, conducting, and reporting audits.
Course-level Learning Objectives (CLOs)
Upon successful completion of this course, students will be able to:

  1. Identify specific FDA regulations that apply to audits for medical device manufacturers.
  2. Discuss the similarities and differences of ISO and FDA regulatory requirements.
  3. Define and differentiate terms associated with quality auditing.
  4. Identify the requirements of a quality audit program using the FDA’s regulatory requirements 21 CFR 820.22 - Quality Audit.
  5. Describe how the FDA regulatory requirements 21 CFR 820.5 - Quality System and 21 CFR 820. 20 - Management Responsibility relate to establishing an audit program policies and procedures.
  6. List and explain the main steps in planning a quality audit in a medical device manufacturing company.
  7. Define corrective actions plans and differentiate between corrective action and preventative action plans.
  8. Identify and list tools used in successful audits including communication techniques, presentation methods, trend analysis, root cause analysis and control charts.
  9. Write an audit plan and report.
  10. Conduct a simulated audit that conforms to FDA regulatory requirements, as a course project.



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