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CHEM ENG 7063 - Good Manufacturing Practice, Validation and Regulation

Career: Postgraduate Coursework
Units: 3
Term: 4120
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

To display course fees, please select your status and program below:

Student Status

Domestic
International

What type of place are you studying in

Commonwealth supported
Full fee paying

Study Level

Undergraduate
Postgraduate Coursework
Non Award

Program of Study

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.

The fees displayed below for international students are for students commencing a program in 2024 only. International students who commenced a program in 2023 or prior can find their fee here.

Units
 EFTSL
Amount
3
 0.125
          
  


Course Outline

A Course Outline which includes Learning Outcomes, Learning Resources, Learning & Teaching for this course may be accessed here


Critical Dates

Term Last Day to Add Online Census Date Last Day to WNF Last Day to WF
4120 Mon 09/08/2021 Wed 18/08/2021 Fri 17/09/2021 Fri 29/10/2021


Class Details

Enrolment Class: Lecture
Class Nbr Section Size Available Dates Days Time Location
26463 LEC0 40 35 This class does not have any timetabled face-to-face sessions. Please check MyUni or contact your Course Coordinator for details.
Note: These lectures are pre-recorded and can be viewed any time after they are published in MyUni. Please check MyUni once enrolled for details regarding when individual lectures will be published.
Related Class: Tutorial
Class Nbr Section Size Available Dates Days Time Location
24526 TU01 20 19 30 Jul - 17 Sep Friday 9am - 11am Engineering & Mathematics, EM212, Teaching Room
8 Oct - 29 Oct Friday 9am - 11am Engineering & Mathematics, EM212, Teaching Room
Note: This class will be delivered face to face.
24527 TU02 20 16 30 Jul - 17 Sep Friday 12pm - 2pm MyUni, OL, Online Class
8 Oct - 29 Oct Friday 12pm - 2pm MyUni, OL, Online Class
Note: This class is for offshore / remote students only. Please refer to MyUni for details once enrolled.