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Graduate Course Proposal Form Submission Detail - EIN6271
Tracking Number - 1886

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

Detail Information

  1. Date & Time Submitted: 2005-01-20
  2. Department: Industrial and Mangement Systems Engineering
  3. College: EN
  4. Budget Account Number: 2103-000-00
  5. Contact Person: Prof. Dolores K. Gooding
  6. Phone: 45582
  7. Email:
  8. Prefix: EIN
  9. Number: 6271
  10. Full Title: Overview of Regulated Industries
  11. Credit Hours: 3
  12. Section Type: C - Class Lecture (Primarily)
  13. Is the course title variable?: N
  14. Is a permit required for registration?: N
  15. Are the credit hours variable?: N
  16. Is this course repeatable?:
  17. If repeatable, how many times?: 0
  18. Abbreviated Title (30 characters maximum): Overview Regulated Industries
  19. Course Online?: -
  20. Percentage Online:
  21. Grading Option: R - Regular
  22. Prerequisites: None
  23. Corequisites: None
  24. 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.

  25. 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
  26. 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.
  27. 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.
  28. 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.

  29. 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.
  30. 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;
  31. 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;
  32. Textbooks: A Practical Guide to Food and Drug Law and Regulation; 2nd Edition; Edited by Kenneth R. Pia, Henkel Corporation, and Wayne L. Pines, Communications Consultant; Publisher: The Food and Drug Law Institute (; US Food and Drug Administration website:;
  33. Course Readings, Online Resources, and Other Purchases:
  34. Student Expectations/Requirements and Grading Policy:
  35. Assignments, Exams and Tests:
  36. Attendance Policy:
  37. Policy on Make-up Work:
  38. Program This Course Supports:
  39. Course Concurrence Information:

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