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Regulatory Affairs

 

Graduate Certificate in Regulatory Affairs

The certificate program in regulatory affairs was developed with input from local medical device companies and faculty in the Regulatory Affairs Program at San Diego State University.  Listed below are the six courses offered on the Tampa Campus as well as on the internet providing access to any one, any where, and any time. The busy professional can access these graduate certificate courses as their schedule allows. 

  1. EIN 6430      Overview of Regulated Industries (medical device emphasis)
  2. EIN 6431      Quality Systems and Control
  3. EIN 6432      Product Approval Process
  4. EIN 6433      Human Factors Engineering for Medical Devices
  5. EIN 6434      Design Controls
  6. EIN 6435      International Regulations

For more information click on program brochure.

For registration (http://www.outreach.usf.edu/gradcerts/)

Moreover, this certificate program is expected to evolve into a formal Masterís degree option in the near future.  In order to become a Masterís degree program, new courses must be added.  One of the planned new courses is a course in the economics of regulation and antitrust, and a second planned new course is the economics of healthcare.  Both of these courses are already offered in the College of Business Administration at USF.

 

 The Aim of the Program

The Master of Science Program in Regulatory Affairs (Medical Device Concentration) is directed toward individuals with technical backgrounds in the medical device / pharmaceutical / regulated industries who currently occupy or are moving into professional regulatory affairs positions. This program develops the requisite compliance skills by combining current regulatory approaches and quantitative techniques in a balanced curriculum, which strengthens compliance credentials and develops professional engineering management competence.

The MSRA Program in the Department of Industrial and Management Systems Engineering at the University of South Florida will prepare today's technical workforce to become tomorrow's medical device professionals.