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Mar 28, 2024
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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:
- Identify specific FDA regulations that apply to audits for medical device manufacturers.
- Discuss the similarities and differences of ISO and FDA regulatory requirements.
- Define and differentiate terms associated with quality auditing.
- Identify the requirements of a quality audit program using the FDA’s regulatory requirements 21 CFR 820.22 - Quality Audit.
- 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.
- List and explain the main steps in planning a quality audit in a medical device manufacturing company.
- Define corrective actions plans and differentiate between corrective action and preventative action plans.
- Identify and list tools used in successful audits including communication techniques, presentation methods, trend analysis, root cause analysis and control charts.
- Write an audit plan and report.
- Conduct a simulated audit that conforms to FDA regulatory requirements, as a course project.
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