BIOT 6310 — CGMP Statutes and Regulation
3 semester hoursGraduateLectureusually offered: fall, springtypical days: WBostonOnlineOnlineTraditional
Focuses on the laws and regulations related to pharmaceuticals manufacture and administration. Discusses an overview of laws and regulations and provides guidance in the context of why they exist, their evolution, and implementation. Specifically focuses on the laws and regulations around good manufacturing practices (GMP), postapproval safety concerns, regulation of manufacture, violations and enforcement, and what to expect during an inspection from a regulatory body. Surveys the laws and regulations on a global level focusing on specific examples related to the United States, Europe, Asia, and other regulatory agencies.
Offering history
| Term | Sections | Enrolled | Capacity | Full | Open seats/section |
|---|---|---|---|---|---|
| Fall 2023 | 1 | 27 | 39 | 69% | 12.0 |
| Spring 2024 | 1 | 13 | 20 | 65% | 7.0 |
| Fall 2024 | 1 | 22 | 35 | 63% | 13.0 |
| Spring 2025 | 1 | 18 | 20 | 90% | 2.0 |
| Fall 2025 | 1 | 19 | 30 | 63% | 11.0 |
| Spring 2026 | 1 | 13 | 20 | 65% | 7.0 |
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 61% · Th 0% · F 0%
Common patterns: W (61% of sections), async (39% of sections) — in patterns, R means Thursday
Professors
Fall
- Beth Zielinski-Habershaw (40% of students) · reviews
- Melissa Liriano-Ng (32% of students)
- Alexander Crone (28% of students) · reviews
Spring
- Beth Zielinski-Habershaw (70% of students) · reviews
- Tarek Zaid (30% of students) · reviews
Percentages are each professor's average share of the season's enrolled students in recent terms.
Links
Official catalog (BIOT course descriptions) · Student reviews on RateMyHusky · All BIOT courses · Plan it at numap.app