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 Master of Science (Good Manufacturing Practices) is part of a nested suite of programs incorporating the Graduate Certificate of Science (Good Manufacturing Practices) , Graduate Diploma of Science (Good Manufacturing Practices) and Master of Science (Good Manufacturing Practices and Quality Management)
Aims & Objectives:
The program aims to: educate students in the fundamental reasons behind the requirement of good manufacturing practicedevelop in students a fundamental understanding of how good manufacturing practice operates and how the pharmaceutical, biotechnology, veterinary, medical and related industries are regulatedprovide 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 master degree is to provide students with an advanced understanding of good manufacturing practices and to provide an avenue for students of exceptional ability and interest to pursue the topic to either: (a) a deep theoretical and practical understanding of a breadth of topics, or (b) a deep theoretical and practical understanding of one area at an advanced research level
Course Structure:
New program structure - effective from 2010 The master program 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. Master students must undertake studies totalling 150 credit points, including an optional minor thesis, over one and half years (full-time) or three years (part-time). International students must 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 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. For the Master of Science (Good Manufacturing Practices), students must complete a total of 150 credit points as follows: four of the five units of study from Group A (50 credit points) compulsorily including HES6401, HES6402 and HES6403 two units of study from Group B (25 credit points)two units of study from Group C (25 credit points) compulsorily including HES6513one unit of study from Group D (12.5 credit points)one unit of study from Group E (12.5 credit points)two units of study from any group (25 credit points) or students may take the research option as follows: four of the five 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)two units of study from Group C (25 credit points) compulsorily including HES6513HES6420 Minor Thesis (50 credit points) or HES6421 Minor Thesis (Part-time) A and HES6422 Minor Thesis (Part-time) Bone unit of study from any group (12.5 credit points) Notes:Students undertaking HES6421 must also undertake HES6422 in the subsequent semester. Electives must be approved prior to enrolment by the program manager or nominee to ensure a sensible theme has been developed within the electives. Staff from Seer Pharma Pty Ltd teach units in this program.
Units of Study:
Units of study for new program stucture - effective from 2010: All units of study are valued at 12.5 credit points (CP) unless indicated otherwise. Group A (Core) HES6401 International Good Manufacturing Practices and Quality AssuranceHES6402 Good Manufacturing Practices for Manufacturing OperationsHES6403 Validation PrinciplesHES6404 Good Quality Control Laboratory Practices HES6405 Contamination ControlGroup 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 Group C (GMP Electives) HES6409 Validation PracticesHES6410 Good Laboratory Practices (for Non-Clinical Laboratories) HES6411 Computer Systems Validation PrinciplesHES6412 Computer Systems Validation PracticesHES6413 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 HES6516 Environmental Management * HES6502 The Microbial World * HES6514 Microbes in the Environment * Group E (Project Units) HES6420 Minor Thesis HES6421 Minor Thesis (Part Time) A HES6422 Minor Thesis (Part Time) B HES6424 Minor Research Project A HES6430 Minor Research Project B HES6425 Major Research Project A (25 CP) HES6431 Major Research Project B (25 CP) * Only available at Hawthorn campus Notes: Students undertaking HES6421 must also undertake HES6422 in the subsequent semester. 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 areasare entrepreneurial in contributing to innovation and development within their business, workplace, or communityoperate effectively and ethically in work and community situationsare adaptable and manage changeare aware of environments in which they will be contributing Swinburne also expects its graduates to have developed the following: teamwork skillsanalysis skillsproblem solving skillscommunications skillsability to tackle unfamiliar problemsability to work independently Since this program requires a degree or equivalent for admission, students are expected to already exhibit most of these graduate attributes. Nevertheless, this program will enhance all of these attributes.
Swinburne expects that its graduates:
Entry Requirements:
To be eligible for admission into the Master of Science (Good Manufacturing Practices), a student should normally have completed an appropriate undergraduate science degree with honours, or an appropriate four-year undergraduate engineering degree with honours. An average of 60% or higher in a four-year undergraduate degree, an honours degree in another discipline with appropriate work experience, or a first degree in science or engineering with appropriate work experience, are examples of an honours equivalence. Students who satisfactorily meet this requirement can enrol directly into the master program or may be allowed to articulate seamlessly from the graduate diploma (assuming successful completion) to the master. Students who do not satisfy this requirement may also be admitted to the master if they achieve a credit average or higher in the Graduate Diploma of Science (Good Manufacturing Practices). International students must 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 successful completion of relevant units in a postrgaduate degree, 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 programs 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:
The total tuition fee is dependent upon the combination of units of study selected by the student. Fees are reviewed each year.For information about Swinburne's fees visit: www.swinburne.edu.au/fees
Application Procedure:
Application forms can be downloaded from the website at: http://www.swinburne.edu.au/postgrad/apply/
Further information:
Web: Enquire online Tel: 1300 ASK SWIN (1300 275 794) Email: postgrad@swinburne.edu.au Website: www.swinburne.edu.au/lss
