Swinburne University of Technology - Melbourne Australia
Future Students - Courses
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 Diploma is part of a nested suite of programs including the Graduate Certificate of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices) (Honours)
Aims & Objectives:
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.
Course Structure:
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 prescribed units, 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 and HES6402 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 or D or minor thesis or research project subjects) (25 credit points) All coursework units of study are offered in block release mode and require three or four full days of class attendance. 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.
Units of Study:
All units of study are valued at 12.5 credit points (CP) unless otherwise indicated and are offered in block release mode only. Each unit of study normally requires three or four full days of class attendance. Group A (Core 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 Group B (Elective units of study I) 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 (Elective units of study II) 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 HES6416 Pharmaceutical Engineering – Facility, Equipment and Process Design HES6513 Research Skills * Group D Subjects (Elective units of study III) HES6417 Microbiology* 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 HES6720 Risk Perception and Analysis * HES6721 Risk Management Principles* HES6722 Quantitative Risk and Modelling * HES6723 Financial Risk Management * HES6724 Risk Management Systems * HBSG200 New Venture Development and Management * HES6424 Minor Research Project A HES6430 Minor Research Project B HES6425 Major Research Project (25 CP) * Only available at the Hawthorn campus Note: 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.
Career Opportunities:
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.
Professional recognition:
Professional recognition from regulatory bodies may be sought.
Graduate Attributes:
Swinburne expects that its graduates: are capable in their chosen professional, vocational or study areas are entrepreneurial in contributing to innovation and development within their business, workplace, or community operate effectively and ethically in work and community situations are adaptable and manage change are aware of environments in which they will be contributing Since this program requires a degree or equivalent for admission, students are expected to already exhibit many of these graduate attributes.
Entry Requirements:
To be eligible for admission into the Graduate Diploma of Science (Good Manufacturing Practices), a student should normally have satisfactorily completed an appropriate undergraduate science or engineering degree, 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). 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. 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.
Credit Transfer:
Successful completion of relevant units of study in a postgraduate degree, or equivalent, can provide entry into this program with advanced standing. A maximum of 25% credit for each stage is permissible except where modules running in the programs have been taken by students as stand-alone fee-paying units, in which case a maximum of 50% credit for each stage is permissible. Applicants will be considered on their individual merits and university policies will apply.
Recognition of Prior Learning:
Relevant industry experience, or equivalent, can provide entry into these programs with advanced standing. A maximum of 25% credit for each stage is permissible except where modules running in the program have been taken by students as stand-alone fee-paying units, in which case a maximum of 50% credit for each stage is permissible. Applicants will be considered on their individual merits and university policies will apply.
Course Fees:
In 2010, tuition fees for this program are based on $2100 per 12.5 credit point unit of study. In the event that a unit of study is derived from another program, the applicable fee will be that of the other program. All fees are reviewed each year and may increase without notice. The Higher Education Loan Program (HELP) is a suite of income contingent loans for Australian citizens and holders of Australian permanent humanitarian visas. FEE-HELP (previously PELS) – is available to eligible fee paying undergraduate and postgraduate students. It provides students with a loan to cover their tuition fees (lifetime maximum $83,313 from 1 January 2009). The FEE-HELP limit is indexed on 1 January each year. Note: New Zealand citizens and holders of other Australian permanent resident visas do not have access to HELP loans. These students must pay their student contributions or tuition fees up front without a discount. For further information on your support and study options visit the 'Going to Uni' website at: http://www.goingtouni.gov.au
Application Procedure:
Application forms can be downloaded from the website at: www.swinburne.edu.au/hed/postgrad/apply 2010 Closing Dates: 19 February for start 1 March16 July for start 9 August
Further information:
Web: Enquire online Tel: 1300 ASK SWIN (1300 275 794) Email: postgrad@swinburne.edu.au Website: www.swinburne.edu.au/lss
