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