Graduate Certificate of Science (Good Manufacturing Practices)
Overview
This program covers the code of conduct referred to as the 'code of Good Manufacturing Practice' (cGMP) which is crucial in the development and manufacturing of new products for the pharmaceutical, biotechnology, veterinary, medical and related industries.
The Graduate Certificate is part of a nested suite of programs including the Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices and Quality Management).
Information sessions
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| Duration | 6 Month/s | ||
Campus and intakes  |
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| Course code | Z0851 | ||
| CRICOS code | 054544K | ||
| Fees* | A$12,475 (total for 2013)* |
*The indicative course fees shown in Course Search apply to international students studying on-campus in Australia for the relevant year only. They are based on a standard study load per year. However, please note that fees are assessed according to a student's study load in each semester, and variation to study load will result in an adjustment to tuition fees. All fees are subject to annual review and may be adjusted.
Course in detail
Course description
This program covers the code of conduct referred to as the 'code of Good Manufacturing Practice' (cGMP) which is crucial in the development and manufacturing of new products for the pharmaceutical, biotechnology, veterinary, medical and related industries.
The Graduate Certificate is part of a nested suite of programs including the Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices and Quality Management).
Course structure
New Program Structure - effective from 2010:
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:
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)
Flexible and block mode delivery may alter time frames but not credit point requirements. Students must undertake four prescribed units of study (50 cp).
International students are required to undertake the program on a full-time basis. While some units of study are available at interstate venues, international students may only undertake the program at the Hawthorn campus.
Interstate (non-Hawthorn campus) domestic applicants should note that some units of study leading to the graduate certificate qualification may not be offered in some capital cities and that progression to the graduate diploma or master level is unlikely due to the unavailability of some units of study at non-Hawthorn campus venues.
Units of study
Units of Study for New Program Structure - effective from 2010:
All units of study are valued at 12.5 credit points unless otherwise specified.
Group A (Core)
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
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
Group B (Process Development Units)
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
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
Group C (GMP Electives)
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 *
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 *
Group D (Electives)
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6427 Chemometrics
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
HES6426 Fundamentals of Process Analytical Technology
HES6427 Chemometrics
HES6428 Design of Experiments
HES6429 Risk Management for Pharmaceutical Operations
HES6516 Environmental Management *
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
HES6502 The Microbial World *
HES6514 Microbes in the Environment *
*Only available at the Hawthorn campus
Notes:
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.
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.
Unit of study availability may vary due to enrolment quotas, timetable constraints, location and staff availability.
Staff from Seer Pharma Pty Ltd teach units in this program.
Graduate outcomes
Aims and objectives
The program aims:
- 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.
Entry requirements
Special entry requirements
Whilst some units in the program are available at interstate venues, international applicants residing in Australia with a current student visa may only undertake the program at the Hawthorn campus.
Academic requirements
To be eligible for admission into the Graduate Certificate of Science (Good Manufacturing Practices), a student should normally have satisfactorily completed an appropriate undergraduate science or engineering degree course, or the equivalent. An advanced diploma with appropriate work experience is one typical example of a degree equivalence. Students who have not completed a degree or advanced diploma may be admitted to the Graduate Certificate on an individual case basis dependent on their work experience including level of responsibility and length of time. Three years experience in a relevant field would normally be required.
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.
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.
Apply
How to apply
Application forms can be downloaded from the website at: http://www.international.swinburne.edu.au/apply/
Course fees*
A$12,475 (total for 2013)*The indicative course fees shown in Course Search apply to international students studying on-campus in Australia for the relevant year only. They are based on a standard study load per year. However, please note that fees are assessed according to a student's study load in each semester, and variation to study load will result in an adjustment to tuition fees. All fees are subject to annual review and may be adjusted.
Scholarships
A range of scholarships are available to international students, visit our Scholarship Page for details.
Find out more
Enquire online: http://www.swinburne.edu.au/international/enquiry
Email: international@swinburne.edu.au
Phone:
+613 8676 7002 (outside Australia)
Freecall 1800 897 973 (within Australia)
