CHEM ENG 7063 - Good Manufacturing Practice, Validation and Regulation
| Career: | Postgraduate Coursework |
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| Units: | 3 |
| Term: | Semester 2 |
| Campus: | North Terrace |
| Contact: | Up to 4 hours per week |
| Available for Study Abroad and Exchange: | Yes |
| Available for Non-Award Study: | Yes |
| Assessment: | Exams, assessments, lab component, in-class quiz |
| Syllabus: |
The aim of this course is to introduce the strategy for producing high quality safe pharmaceutics. This module will focus on the traditional approaches to ensure product quality using facility design, validation and good manufacturing practice (GMP). The concepts of quality by design (QbD), process analytical technology (PAT) and continuous manufacturing will be introduced. Special reference will be made to the manufacture of biologics including antibiotics, therapeutic proteins and vaccines. |
Course Fees
Study Abroad student tuition fees are available here
Only some Postgraduate Coursework programs are available as Commonwealth Supported. Please check your program for specific fee information.
| EFTSL | |||
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| 0.125 | |||
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Course Outline
A Course Outline which includes Learning Outcomes, Learning Resources, Learning & Teaching for this course may be accessed here
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Critical Dates
| Term | Last Day to Add Online | Census Date | Last Day to WNF | Last Day to WF |
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| Semester 2 | Mon 11/08/2025 | Wed 20/08/2025 | Fri 19/09/2025 | Fri 31/10/2025 |
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Class Details
| Enrolment Class: Workshop | |||||||
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| Class Nbr | Section | Size | Available | Dates | Days | Time | Location |
| 22623 | WR01 | 10 | 1 | 28 Jul - 8 Sep | Monday | 1pm - 3pm | Lower Napier, LG23, Teaching Room |
| 1 Aug - 12 Sep | Friday | 9am - 11am | Lower Napier, LG23, Teaching Room | ||||
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