BIOT2000
QA/QC:QUALITY BY DESIGN BIOPHA
- Department
- Biotechnology
- Terms offered
- 1
- Data refreshed
- Jun 27, 2026
Description
This course provides an examination of the application of quality practices in the development, manufacturing, control and assessment of products in the biotechnology and biopharmaceutical industries. Students learn the principles of Quality-by-Design (QbD) and Quality Management System (QMS) as they apply them to the development of drugs from discovery to commercialization. Through sample exercises, the course presents the commonalities of QMS and the application of GxP (Good laboratory, Clinical, Manufacturing Practices) for many product types, as well as the specific requirements and differences among biologics, small molecules and devices.
Syllabi
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Offering history & forecast 2023
2023
| Year | Fall | Spring | Summer | Intersession |
|---|---|---|---|---|
| 2030 | 2030 Fall: not enough history to forecast. | 2030 Spring: not enough history to forecast. | 2030 Summer: not enough history to forecast. | 2030 Intersession: not enough history to forecast. |
| 2029 | 2029 Fall: not enough history to forecast. | 2029 Spring: not enough history to forecast. | 2029 Summer: not enough history to forecast. | 2029 Intersession: not enough history to forecast. |
| 2028 | 2028 Fall: not enough history to forecast. | 2028 Spring: not enough history to forecast. | 2028 Summer: not enough history to forecast. | 2028 Intersession: not enough history to forecast. |
| 2027 | 2027 Fall: not enough history to forecast. | 2027 Spring: not enough history to forecast. | 2027 Summer: not enough history to forecast. | 2027 Intersession: not enough history to forecast. |
| 2023 | 1 section | Not offered | Not offered | Not offered |
Future estimates combine recent offering frequency with detected multi-year cycles. Hover a cell for confidence and evidence; low-confidence estimates are marked with ~.
Meeting times
Most recent firstNo meeting times recorded for this course.
| Term | Professor | Type | Credits | Enrollment | CRN |
|---|---|---|---|---|---|
| Fall 2023 | Kevin J. Slatkavitz | Online | 1 | 2 of 20 enrolled | 22726 |