Medical Education

Quality Assurance and Regulatory Affairs Certificate Program

Formative & Summative Evaluation

Overview

The Quality Assurance and Regulatory Affairs (QA/RA) Certificate Program is an interdisciplinary program designed to upskill or reskill aspiring or working professionals interested in expanding their knowledge of how to bring a medical product to market including regulations, quality management systems, risk management, compliance, auditing and inspection metrics, design controls, and best practices. 

Evaluation Approach

The Evaluation Center will collect student surveys to assess curriculum knowledge, skills gained, and satisfaction with program components. Evaluators will collect surveys with program alumni as they enter the workforce to assess job placement, job advancement, and how well prepared they were to complete new job duties. Surveys with industry stakeholders will collect feedback on perceptions of changes to workforce development pipeline for open positions, hiring barriers, and suggestions for program improvement.  

 

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Timeline

October 2025  September 2028

POPULATION SERVED

Undergraduate and graduate students, career-switchers, and working professionals