Curricular information is subject to change.
On completion of this module students should be able to:
1. Define the principal implications of cGMPs and understand their specific application throughout the product lifecycle
2. Understand the regulatory bodies and their guidelines that govern the biopharmaceutical industry.
3. Outline procedures for managing compliance based on the cGMPs for the 21st Century initiative
| Student Effort Type | Hours |
|---|---|
| Lectures | 16 |
| Autonomous Student Learning | 90 |
| Total | 106 |
Not applicable to this module.
| Description | Timing | Component Scale | % of Final Grade | ||
|---|---|---|---|---|---|
| Exam (Online): Assessment 1: MCQ exam | Week 4 | Standard conversion grade scale 40% | No | 20 |
No |
| Exam (Online): Assessment 2: MCQ exam | Week 8 | Standard conversion grade scale 40% | No | 20 |
No |
| Assignment(Including Essay): Assignment linked to EudraLex Volume 4 Annex I regulations | Week 14 | Standard conversion grade scale 40% | No | 60 |
No |
| Resit In | Terminal Exam |
|---|---|
| Spring | No |
• Feedback individually to students, post-assessment
Not yet recorded.
| Name | Role |
|---|---|
| Professor Niall Barron | Lecturer / Co-Lecturer |
| John Milne | Lecturer / Co-Lecturer |