Temple University School of Pharmacy 6 courses 12 total credits
The post-master's certificate in Pharmaceutical Manufacturing: Process Development and Analysis is designed to enhance students' understanding of the science and regulations involved in pharmaceutical manufacturing processes. Through coursework, students learn how to set standards for increasing product quality, improve plant efficiency, lower production costs, and meet current domestic and global compliance requirements. The curriculum also reflects the culture of meeting continuous manufacturing quality, such as the Food and Drug Administration's Quality Metric Guidance document and its focus on data integrity, change control, quality risk management, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
| Total Credits | 12 credits |
Core Courses
| Code | Course Title | Credits |
|---|---|---|
| QARA 5622 | Unit Operations | 3 |
| QARA 5627 | Statistical Design of Experiments (DOE) | 3 |
| QARA 5629 | Process Monitoring | 3 |
Elective
| Code | Course Title | Credits |
|---|---|---|
| QARA 5512 | Microbiological Concepts in Pharmaceutical Manufacturing | 3 |
| QARA 5548 | Risk Management of Pharmaceutical and Medical Devices | 3 |
| QARA 5625 | Process Analytical Technology (PAT) | 3 |
| Total Elective | 3 credits | |
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