Graduate Course Proposal Form Submission Detail - EIN6275
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Course Change Information (for course changes only):
- Department and Contact Information
Tracking Number Date & Time Submitted 1882 2005-01-20 Department College Budget Account Number Industrial and Mangement Systems Engineering EN 2103-000-00 Contact Person Phone Prof. Dolores K. Gooding 45582 email@example.com
- Course Information
Prefix Number Full Title EIN 6275 Design Controls for Medical Devices 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) Design Controls Med Dev Course Online? Percentage Online -
Overview Regulated Industries or by permission of Instructor
The course provides students with information to establish procedures to effectively control the design requirements and specifications for medical devices. The design process will be examined to apply the best approaches for verification and validation.
A. 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 integrity of the design requirements and design specifications processes will be discussed.
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?
No. This course has not been offered previously.
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.
- Other Course Information
The course provides students with information to establish and maintain procedures to effectively control the design requirements and specifications for medical devices. Each phase of the design process will be examined to apply the best approaches to ensure design input requirements and design output specifications are in alignment.
B. Learning Outcomes
At the end of the course the student will: Develop and maintain an effective design control system; Describe the phases of design: planning, input, output, verification, validation, transfer and changes; Develop the components of a design history file and effectively maintain such; Perform software validation and product risk analysis;
C. Major Topics
Design input or requirements identification; Design output or specifications development; Design test process for verification; Design test process for validation; Software validation process; Device design to production specifications transferal; Risk analysis; Design changes during the design process; Post-market product design changes;
Practical Design Control Implementation for Medical Devices; Author: Jose M. Justiniano, Venky Gopalaswamy; Publisher: CRC Press; Reference website: http://www.fda.gov/cdrh/qsr/03desgn.html;
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
- Course Concurrence Information