Graduate Certificate of Science (Good Manufacturing Practices)
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|Campus and intakes|
|Fees*||A$12,475 (total for 2013)*|
Course in detail
The Graduate Certificate of Science (Good Manufacturing Practices) is the first stage in a nested suite of postgraduate programs including the Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and the Master of Science (Good Manufacturing Practices and Quality Management). Students undertaking the graduate certificate must complete a total of four units of study (totalling 50 credit points), normally over six months (full-time) or one year (part-time) as follows:
- HES6401 International GMPs and Quality Assurance (core unit)
- HES6402 GMP for Manufacturing Operations (core unit)
- one unit of study from Group A
- one unit from any group (Group A, B, C, D or E)
Units of study
HES6401 International Good Manufacturing Practices and Quality Assurance
HES6402 Good Manufacturing Practices for Manufacturing Operations
HES6403 Validation Principles
HES6404 Good Quality Control Laboratory Practices
HES6405 Contamination Control
HES6406 Process Development for Therapeutics (A) – A Perspective for Protein Therapeutics *
HES6407 Process Development for Therapeutics (B) – A Perspective for Small Molecules *
HES6408 Process Development for Therapeutics (C) – A Perspective for Medical Devices *
HES6423 Process Development for Therapeutics (D) – Perspective for Pharmaceutical Finished Dose Forms
HES6409 Validation Practices
HES6410 Good Laboratory Practices (for Non-Clinical Laboratories)
HES6411 Computer Systems Validation Principles
HES6412 Computer Systems Validation Practices
HES6413 Good Aseptic Practices and Sterile Products
HES6414 Clinical Trials Quality Assurance Management
HES6415 GxP and Quality Auditing Practices
HES6513 Research Skills *
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
Elective units of study may be added or removed from time to time as determined by the program manager and Faculty of Life and Social Sciences Academic Committee.
Aims and objectives
- to educate students in the fundamental reasons behind the requirement of good manufacturing practice
- to develop in students a fundamental understanding of how good manufacturing practice operates and how the pharmaceutical, biotechnology, veterinary, medical and related industries are regulated
- to provide students with a theoretical understanding and practical experience in microbiological aspects of pharmaceutical manufacturing, cleaning and sanitation, documentation and record keeping, manufacturing and packaging, process control measures, supervisory responsibility, validation, quality audits, quality management, process development, clinical study requirements, regulatory body requirement, quality assurance and quality control
- The specific objective of the graduate certificate is to provide interested students with an introduction to good manufacturing practices and to provide a qualification for those students who have been introduced to the topic but who do not want to develop to a significantly deep enough level to qualify for a graduate diploma.
Special entry requirements
International students are required to undertake the program on a full-time basis. Whilst some units of study are available at interstate venues, international students may only undertake the program at the Hawthorn Ccampus.
English language requirements
Swinburne College English for Academic Purposes Certificate: EAP 5 Advanced: 70%; OR, obtaining a minimum IELTS overall band of 6.5 (Academic Module) with no individual band below 6.0; OR, a TOEFL (Paper-based) minimum score of 550 (with Test of Written English (TWE) score of 5); OR, a TOEFL (Internet-based) minimum score of 79, with no individual band below 18. Refer to the English Language Requirements website for further information.
How to apply
Course fees*A$12,475 (total for 2013)
A range of scholarships are available to international students, visit our Scholarship Page for details.