BME-401-davidlin-2026-08-14-09-34-41
Title of Course: Biomedical Engineering Regulatory and Quality Science
Prefix and Number: BME 401
Semester and Year: tbd
Number of Credit Hours: 3
Prerequisites: BME 301 (or alternative professional ethics course, subject to instructor approval), STAT 370 (or alternative statistics class, subject to instructor approval)
Course Details
Day and Time: tbd
Meeting Location: tbd
Instructor Contact Information
Instructor Name: tbd
Instructor Contact Information: tbd
Instructor Office Hours: tbd
TA Name: tbd
TA Contact Information: tbd
TA Office Hours: tbd
Course Description
Provides skills for working in life sciences industry with emphasis on manufacturing of pharmaceuticals, biologics, and medical devices. Introduces validation, quality control, and manufacturing process. Focuses on testing, systems evaluations, FDA compliance, and reporting.
Course Materials
Books: none
Other Materials: reading material will be provided
Fees: none
|
Course Learning Outcomes (students will be able to:) |
Activities Supporting the Learning Outcomes | Assessment of the Learning Outcomes |
|---|---|---|
| Explain the drug and medical device approval process in the United States. | Lecture, reading, and writing assignments. | Writing assignments |
| Define, obtain the regulatory codes, and describe the FDA’s guidance strategy for Quality Control System. | Lecture, reading, and writing assignments. | Writing assignments |
| Develop regulatory documentation (standard operating procedure and batch record) for a given process. |
Lecture, reading, and writing assignments. |
Writing assignments |
| Develop a written validation report for a given process, equipment, or analytical method. |
Lecture, reading, and writing assignments. |
Writing assignments |
| Design a FDA compliance plan and describe it in a detailed document (quality plan). |
Lecture, reading, and writing assignments. |
Writing assignments |
| Dates | Lesson Topic | Assignment | Assessment |
|---|---|---|---|
|
Week 1 |
Syllabus, course overview, and expectations |
Lecture |
|
|
Week 2 |
Need for regulatory control |
Lecture |
Writing assignment |
|
Week 3 |
Medical Devices: Product Life Cycle & Project; Management Tools |
Lecture |
Writing assignment |
|
Week 4 |
Quality System and Regulatory Submissions |
Lecture |
Writing assignment |
|
Week 5 |
Prototyping and User Needs |
Lecture |
Writing assignment |
|
Week 6 |
Design Controls |
Lecture |
Writing assignment |
|
Week 7 |
Verification & Validation of a Medical or Diagnostic Device |
Lecture |
Writing assignment |
|
Week 8 |
Medical Device Statistics |
Lecture |
Writing assignment |
|
Week 9 |
Manufacturing Processes, Outsourcing, Suppliers |
Lecture |
Writing assignment |
|
Week 10 |
Manufacturing Technology |
Lecture |
Writing assignment |
|
Week 11 |
Regulatory Affairs/Corporate Submission (Post-Launch) and Reimbursement |
Lecture |
Writing assignment |
|
Week 12 |
Types of Intellectual Property and their creation and protection |
Lecture |
Writing assignment |
|
Week 13 |
Preclinical Studies and Animal Model Selection |
Lecture |
Writing assignment |
|
Week 14 |
Student FDA compliance plans |
Presentations |
|
|
Week 15 |
Student FDA compliance plans |
Presentations |
Final report |
Expectations for Student Effort
For each hour of lecture equivalent, students should expect to have a minimum of two hours of work outside of class.
Grading
| Type of Assignment (tests, papers, etc) | Points | Percent of Overall Grade |
|---|---|---|
| Writing assignments | 40% | |
| Class Participation | 10% | |
| Regulatory Compliance Plan (written and oral) | 50% |
There will be weekly writing assignment on a topic covered in lectures and/or reading assignments. You will be able to revise one of the weekly writing assignment based on instructor feedback. The final report will FDA compliance plan and be graded according the rubric provided. You can revise the final report based on instructor feedback if you submit a draft by the specified deadline.
| Grade | Percent | Grade | Percent |
|---|---|---|---|
| A |
>92 |
C | 73-76 |
| A- | 90-91 | C- | 70-72 |
| B+ | 87-89 | D+ | 67-69 |
| B | 83-86 | D | 60-66 |
| B- | 80-82 | F | <60 |
| C+ | 77-79 |
Numerical grades will be rounded to the nearest integer value.
Attendance and Make-Up Policy
Students should make all reasonable efforts to attend all class meetings. However, in the event a student is unable to attend a class, it is the responsibility of the student to inform the instructor as soon as possible, explain the reason for the absence (and provide documentation, if appropriate), and make up class work missed within a reasonable amount of time, if allowed. Missing class meetings may result in reducing the the class participation grade.
Academic Integrity Statement
You are responsible for reading WSU's Academic Integrity Policy, which is based on Washington State law. If you cheat in your work in this class you will:
-All information from outside sources shall be properly cited; failure to do so will be considered plagiarism. Cases of plagiarism or cheating will result in a grade of “0” for that assignment.
-Be reported to the Center for Community Standards
-Have the right to appeal my decision
-Not be able to drop the course of withdraw from the course until the appeals process is finished
If you have any questions about what you can and cannot do in this course, ask me.
If you want to ask for a change in my decision about academic integrity, use the form at the Center for Community Standards website. You must submit this request within 21 calendar days of the decision.