Swinburne University of Technology - Melbourne Australia
Future Students - Courses
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. It also covers Quality Management (QM) within the same industries and its role as an overseer of cGMP. It is designed to be at an advanced level and will introduce students to both theory and research aspects of science (cGMP and QM).
Course Description:
The Master of Science (Good Manufacturing Practices and Quality Management) 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) From Semester 1 2011, this program replaces the Master of Science (Good Manufacturing Practices) (Honours). In 2011, re-enrolling students may choose to remain enrolled in Z0854 Master of Science (Honours) (Good Manufacturing Practices) program or apply to transfer to Z0855 Master of Science (Good Manufacturing Practices and Quality Management). (International students are required to study full-time.)
Aims & Objectives:
The program aims to: educate students in the fundamental reasons behind the requirement of good manufacturing practice and quality management;develop in students a fundamental understanding of how good quality management and manufacturing practice operates and how the pharmaceutical, biotechnology, veterinary, medical and related industries are regulated;provide students with 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;instil in students a research ethic and methodology enabling good quality scientific research. The specific objective of this 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 develop both breadth and depth of theoretical and practical understanding of the topic.
Course Structure:
The Master of Science (GMP & QM) 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 200 credit points, including a compulsory thesis, over two years (full-time) or four 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 and Quality Management), students must complete a total of 200 credit points as follows: all five units of study from Group A (62.5 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 HES6513 HES6429 or HES6516 as a Group D unit of study (12.5 credit points) one or two units of study from Group E (25 credit points) ** four units of study from any group (50 credit points) ** Notes: ** Students who elect to undertake HES6420 Minor Thesis (50 cp) will be completing an additional 25 credit points from Group E, and will therefore only be required to complete two units of study (25 cp) from any group. 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, in which quality management is developed, has been developed within the electives. Staff from Seer Pharma Pty Ltd teach units in this program. (International students are required to study full-time.)
Units of Study:
Units of Study: (all units are valued at 12.5 credit points (cp) unless indicated otherwise) 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 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 Group C (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 * 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 (50cp) HES6421 Minor Thesis (Part Time) A (25 cp) HES6422 Minor Thesis (Part Time) B (25 cp) 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.
Units of Study: (all units are valued at 12.5 credit points (cp) unless indicated otherwise)
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. Swinburne also expects its graduates to have developed the following: teamwork skillsanalysis skillsproblem-solving skillscommunication 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 also expects its graduates to have developed the following:
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.
Entry Requirements:
To be eligible for admission into the Master of Science (Good Manufacturing Practices and Quality Management), 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 program. Students who do not satisfy this requirement may also be admitted to the Master program if they achieve a credit average or higher in the Graduate Diploma of Science (Good Manufacturing Practices).
Recognition of Prior Learning:
Relevant industry experience or successful completion of relevant/equivalent units in a postgraduate 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:
Applications submission details can be found on the application form and can be downloaded from the website at: www.swinburne.edu.au/hed/postgrad/apply.
Further information:
Web: Enquire online at www.swinburne.edu.au/hed/postgrad/apply.Tel: 1300 ASK SWIN (1300 275 794) Email: postgrad@swinburne.edu.au
