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Master of Science (Good Manufacturing Practices) 

Z0853

Campus Availability

Study Mode

Study Level

Duration

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Hawthorn

Block Release, Full-time, Part-time (day & evening)

Postgraduate

1.5 years full-time or 3 years part-time

Ongoing

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 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


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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 HES6513
  • one 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 HES6513
  • HES6420 Minor Thesis (50 credit points) or  
    HES6421 Minor Thesis (Part-time) A and HES6422 Minor Thesis (Part-time) B
  • one 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.


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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. 
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 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.


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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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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 skills
  • analysis skills
  • problem solving skills
  • communications skills
  • ability to tackle unfamiliar problems
  • ability 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.


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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.


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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.


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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.


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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


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


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Web: Enquire online

Tel: 1300 ASK SWIN (1300 275 794)
 


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