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An Emerging Course Topic: The Regulation of Pharmaceuticals and Medical Devices

Christine Kelly

Department of Chemical Engineering, Oregon State University

Introduction

This paper describes a new course in the area of the regulatory environment for pharmaceutical products and medical devices. The course was offered for the first time in the fall of 2004 as a required course in the undergraduate Bioengineering Program housed within the Chemical Engineering Department at Oregon State University (OSU). The course was a ten week quarter system course worth three credits.

Motivation

The motivation for development of this course was regulated industry employers’ criticism that new engineers are uninformed of the regulatory driving forces that influence engineering practice in their companies. Young engineers spend a significant amount of time learning regulatory issues at expense to the company and detriment to their learning curve for the new position. The course was developed by faculty and a pharmaceutical company employee who worked in the areas of validation and quality control.

Learning Objectives

Five course learning objectives were provided to the students at the beginning of the fall 2004 term, and two will be added for the next offering. These seven learning objectives are indicated in Table 1.

Course Content

The course provided an overview of work in a regulated environment, using a biopharmaceutical manufacturing facility as the example environment. Figure 1 illustrates the topics presented in the course. The seven major topics include (1) the drug and medical device approval process, (2) current good manufacturing practices, (3) biopharmaceutical processing overview, (4) process documentation (primarily standard operating procedures and batch records), (5) validation, (6) quality assurance, quality control and analytical methods, and (7) control strategies. Required readings supplemented the lecture material and are indicated in Table 2.

“Proceedings of the 2005 American Society for Engineering Education Annual Conference & Exposition Copyright © 2005, American Society for Engineering Education”

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Kelly, C. (2005, June), An Emerging Course Topic: The Regulation Of Pharmaceuticals And Medical Devices Paper presented at 2005 Annual Conference, Portland, Oregon. 10.18260/1-2--15086