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Graduate Diploma of Science (Good Manufacturing Practices)

Z0852  054545J



Duration

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Fee*
1 Year/s Hawthorn (Semester 1, Semester 2) A$23,200 (annual for 2012) 
*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.

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.
 

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The program aims to:
  • educate students in the fundamental reasons behind the requirement of good manufacturing practice
  • develop in students a fundamental understanding of how good manufacturing practice operates and how the pharmaceutical, biotechnology, veterinary, medical and related industries are regulated
  • provide for students a theoretical understanding as well as 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 diploma is to provide students with a sound basis in good manufacturing practices and to provide a world-recognised standard qualification in the area.

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New program structure for students commencing in 2010:
The graduate diploma is one of a nested suite of postgraduate programs in Good Manufacturing Practices. Flexible and block mode delivery may alter time frames but not credit point requirements. Students must undertake eight units of study (100 cp), nominally over one year (full-time) or two years (part-time).
 
Students undertaking the graduate diploma program must complete 100 credit points of study as follows:
  • four of the five core units of study from Group A (50 credit points), compulsorily including HES6401, HES6402 and HES6403
  • one unit of study from Group B (12.5 credit points)
  • one unit of study from Group C (12.5 credit points)
  • two units of study from any group (A, B, C, D or E)  (25 credit points)
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 may not be offered in some capital cities and that completion of  the graduate diploma or master level of the good manufacturing suite of programs is unlikely due to the unavailability of some units of study at non-Hawthorn campus venues.

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Units of study  for students commenncing in 2010:
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 *

Group D (Electives)
HES6418 Chemical Analysis of Pharmaceuticals *
HES6419 Environmental Testing and Water Science *
 
* 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.
 
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.

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The program is primarily aimed at laboratory staff, managers and practitioners in industries where good manufacturing practice is required. Completion of this program is expected to enhance employability and career positioning within companies.

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Professional recognition from regulatory bodies may be sought.

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Application forms can be downloaded from the website at: http://www.swinburne.edu.au/postgrad/apply/

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Swinburne College English for Academic Purposes Advanced level certificate at the postgraduate level (EAP 5: PG-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 575 (with Test of Written English (TWE) score of 5); OR, a TOEFL (Computer-based) minimum score of 232 (with Written Writing score of 5); OR, a TOEFL (Internet-based) minimum score of 90 with no band less than 20.

 

Refer to the English Language Requirements website for further information.

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To be eligible for admission into the Graduate Diploma of Science (Good Manufacturing Practices), a student should normally have completed satisfactorily 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 satisfactorily meet this requirement can enrol directly into the Graduate Diploma or may be allowed to articulate seamlessly from the Graduate Certificate (assuming successful completion) to the Graduate Diploma. Students who do not satisfy this requirement may also be admitted to the Graduate Diploma if they achieve a credit average or higher in the Graduate Certificate of Science (Good Manufacturing Practices).

 
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 campus.

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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)

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Visit our Meet Us page to see when we are visiting your home country (or here in Australia)

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A range of scholarships are available to international students, visit our Scholarship Page for details.

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