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 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 Z0854 Master of Science (Honours) (Good Manufacturing Practices).
Aims & 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.
The program aims:
Course Structure:
The Graduate Certificate of Science (Good Manufacturing Practiced) is the first stage in a nested suite of postgraduate programs including the Graduate Diploma of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices) and the Z0854 Master of Science (Honours) (Good Manufacturing Practices). Students undertaking the graduate certificate must complete a total of four units of study (totalling 50 credit points) 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 or D) All units of study are offered in block release mode and require three or four full days of class attendance. Flexible and block mode delivery may alter time frames but not credit point requirements. Students must undertake four prescribed units of study over one year (part-time) or one semester (full-time). 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:
All units of study are valued at 12.5 credit points and are offered in block release mode only. Each coursework 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 (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 * 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.
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, 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 have not completed a degree or advanced diploma may be admitted to the graduate certificate on a case-by-case basis, dependent on their work experience including level of responsibility and duration. Three years experience in a relevant field would normally be required. 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 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 these programs with advanced standing. A maximum of 25% credit for each stage is permissible except where modules running in the course have been taken by students as stand-alone fee-paying units of study, 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 2009, tuition fees for this program are based on $2050 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:
For March 2009 entry: Applications for Semester 1 will be accepted until Friday 20 February 2009. Applications may be posted or submitted in person at the Student Information Centre on any campus. Application forms can be downloaded from the website at: http://www.swin.edu.au/hed/postgrad/postgrad_application.pdf
Information Sessions:
Postgrad City Session Question Everything in the one spot Wednesday 1 July 2009 6.00pm - 8.30pm Melbourne CBD Attend the Swinburne Postgraduate Q&A night in the city to find out more about Mid-year entry for postgrad programs. Register online now www.swinburne.edu.au/citysession
Further information:
Web: Enquire online Tel: 1300 ASK SWIN (1300 275 794) Email: postgrad@swinburne.edu.au Website: www.swinburne.edu.au/lss
