BTC 4450 — Quality Control and Validation Issues
3 semester hoursUndergraduateLectureusually offered: springtypical days: WBostonHybrid
Introduces the regulations and guidelines affecting the development, production, registration, and sale of medical devices, diagnostics, pharmaceuticals, and biotechnology products worldwide. Focuses on why regulations are necessary, ethical considerations, and international standards. Offers practical instruction in the basics of quality control and process/facility validation for the biotechnology industry. Reviews appropriate regulations, including personnel and process flow, environmental and water testing, sterility testing, and incoming material and in-process testing. Other topics include the establishment of a master validation plan; description of facility, equipment, and process validations; and cleaning validations.
Prerequisites
Offering history
| Term | Sections | Enrolled | Capacity | Full | Open seats/section |
|---|---|---|---|---|---|
| Spring 2026 | 1 | 14 | 30 | 47% | 16.0 |
Snapshots from scheduled scrapes — not live seat availability. "Full" can exceed 100% when sections over-enroll.
Meeting times
Share of recent sections by weekday: M 0% · T 0% · W 100% · Th 0% · F 0%
Common patterns: W (100% of sections) — in patterns, R means Thursday
Professors
Spring
- Lara Milane (100% of students) · reviews
Percentages are each professor's average share of the season's enrolled students in recent terms.
Links
Official catalog (BTC course descriptions) · All BTC courses · Plan it at numap.app