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Graduate Course Proposal Form Submission Detail - EIN6272
Tracking Number - 1885

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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: 6272
  10. Full Title: Regulated Quality Systems and Control
  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): Regulated Quality Sys/Ctrl
  19. Course Online?: -
  20. Percentage Online:
  21. Grading Option: R - Regular
  22. Prerequisites: Overview Regulated Industries or by permission of Instructor
  23. Corequisites: None
  24. Course Description: This course provides students with information to design quality systems for regulated industries, emphasizing medical device manufacturing. The application of various statistical techniques to the control of industrial processes will be used.

  25. Please briefly explain why it is necessary and/or desirable to add this course: This course teaches a vital component of regulatory affairs specifically in medical device manufacturing environments. Major topics related to the design, maintenance and auditing of quality systems in regulated industrues will be discussed using statisti
  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 previously 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: The course provides students with information to design and maintain quality systems for regulated industries (bioscience, pharmaceutical and medical devices), with particular emphasis on medical device development, manufacture and commercialization. The application of various statistical techniques to the control of industrial processes will be used.
  30. Learning Outcomes: At the end of the course the student will: Understand the history and variations of quality system implementation in the distinctive regulated industries; Describe the key factors associated with product evaluation; Analyze the effectiveness of a quality system using statistical techniques; Identify the key elements of an effective system to handle complaints; Describe each component of the quality system in a regulated environment and the domestic and international standards that must be satisfied;
  31. Major Topics: Current Good Manufacturing Practices (GMP) ; Current Good Clinical Practices (GCP); The Quality System Regulation (QSR); ISO Requirements (ISO); Buildings and Environment ; Equipment and Calibration; Purchasing and Acceptance Activities; Labeling and Packaging; Product Evaluation; Storage, Distribution, and Installation; Complaints; Quality Systems Audits; Factory Inspections;
  32. Textbooks: The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices; Compiled by: Kimberley A. Trautman; Publisher: ASQ Press; FDA QSR Manual Online:;
  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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