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Graduate Course Proposal Form Submission Detail - EIN6271

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Current Status: Approved, Permanent Archive - 2005-05-04
Submission Type:
Course Change Information (for course changes only):

  1. Department and Contact Information

    Tracking Number Date & Time Submitted
    1886 2005-01-20
    Department College Budget Account Number
    Industrial and Mangement Systems Engineering EN 2103-000-00
    Contact Person Phone Email
    Prof. Dolores K. Gooding 45582

  2. Course Information

    Prefix Number Full Title
    EIN 6271 Overview of Regulated Industries

    Is the course title variable? N
    Is a permit required for registration? N
    Are the credit hours variable? N
    Is this course repeatable?
    If repeatable, how many times? 0

    Credit Hours Section Type Grading Option
    3 C - Class Lecture (Primarily) R - Regular
    Abbreviated Title (30 characters maximum)
    Overview Regulated Industries
    Course Online? Percentage Online





    Course Description

    This course provides students with basic information on regulated industries, emphasizing challenges experienced in medical device development, manufacture and commercialization with regard to regulatory requirements. Unrestricted. Nonrepeatable.

  3. Justification

    A. Please briefly explain why it is necessary and/or desirable to add this course.

    This course teaches important attributes of regulatory affairs specifically in medical device manufacturing environments. Major topics related to the formation of the industry, history of the legal framework governing the industry, and quality procedures

    B. What is the need or demand for this course? (Indicate if this course is part of a required sequence in the major.) What other programs would this course service?

    This course serves as an elective in the MS in Engineering Management program, and MS and PhD programs in Biomedical Engineering. It is also a required course in the Graduate Certificate in Regulatory Affairs.

    C. Has this course been offered as Selected Topics/Experimental Topics course? If yes, how many times?

    Yes. This course has been offered on 1 occasion.

    D. What qualifications for training and/or experience are necessary to teach this course? (List minimum qualifications for the instructor.)

    The instructor should possess the following qualifications at a minimum:

    A master's degree in Industrial Engineering or other technical discipline, plus experience in a relevant technical environment with a focus in regulatory affairs. An individual with an earned PhD with the above listed expertise is preferred.

  4. Other Course Information

    A. Objectives

    Provides students with information on regulated industries (bioscience, pharmaceutical and medical devices), with particular emphasis on challenges experienced in medical device development, manufacture and commercialization with regard to regulatory requirements.

    B. Learning Outcomes

    At the end of the course the student will: Understand the history and philosophical context of regulatory affairs; Understand the history and structure of the FDA; Identify the role of regulatory compliance as it relates to global competitiveness; Describe management roles and responsiblities in an FDA regulated organization; Define the major components of a quality system for a regulated industry; Identify current major issues in domestic and international regulations;

    C. Major Topics

    History of the formation and development of the biotechnology sector in domestic and international markets; Distinction of three industries that form biotechnology sector from a regulatory compliance perspective (bioscience, pharmaceuticals, medical devices); History and structure of the FDA; State regulations (Agencies and procedures); International regulations; Quality Assurance / Quality Control; Clinical Trials; Human Factors; Design Controls; Reimbursement;

    D. Textbooks

    A Practical Guide to Food and Drug Law and Regulation; 2nd Edition; Edited by Kenneth R. Piña, Henkel Corporation, and Wayne L. Pines, Communications Consultant; Publisher: The Food and Drug Law Institute (; US Food and Drug Administration website:;

    E. Course Readings, Online Resources, and Other Purchases

    F. Student Expectations/Requirements and Grading Policy

    G. Assignments, Exams and Tests

    H. Attendance Policy

    I. Policy on Make-up Work

    J. Program This Course Supports

  5. Course Concurrence Information

- if you have questions about any of these fields, please contact or