About This Course
There’s much to learn when it comes to designing, developing, manufacturing, and selling a thing, but this course skillfully covers it all while teaching how to successfully commercialize a product, too. In Regulated Industry Compliance, students will dig into real-world analysis for regulating production of any kind of product—from a box of breakfast cereal to a medical device.
After this course, you’ll be able to: a) improve efficiency in any part of a product’s lifecycle; b) develop soft skills needed to clearly communicate your ideas for improvement; and c) fully wrap your brain around human factors and customer requirements that must be considered before the product’s development is set.
Ultimately, this course teaches and applies methods and techniques that will allow you to step in and make an immediate contribution to improving a company’s processes in any part of the product life cycle you land—beginning, middle, or end. This material has endless application in the workplace.
Sample textbook: Harnack, G. (1999). Mastering and Managing the FDA Maze: Medical Device Overview: A Training and Management Desk Reference for Manufacturers Regulated by the Food and Drug Administration. Milwaukee, WI: ASQ Quality Press.
M.B.A., University of Dallas; B.S., industrial technology, Iowa State University
Mac McKeen, FRAP, is a Fellow at Boston Scientific, with over 25 years of experience in regulatory and quality roles in the development, clinical study, and regulatory approvals of cardiovascular devices. Mac has served as director of regulatory management for Cardiac Science and St. Jude Medical; director of quality and regulation for Phillips Medisize; and leadership roles at Medtronic and Guidant. He collaborates with the FDA through industry associations including AdvaMed and Medical Alley. He maintains R.A.C. (Regulatory Affairs Certification) and has been named a 2020 RAPS (Regulatory Affairs Professionals Society) Fellow in recognition of his regulatory expertise.
- MM 4045 - Regulated Industry Compliance
- MM 4193 - Capstone Directed Study