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Graduate Certificate of Science (Good Manufacturing Practices) 

Z0851     


Study Mode Study Level Duration Campus and Intake Show intake calendar
Block Release
Full-time
Part-time (day & evening) 		Postgraduate 6 months full-time or 1 year part-time Hawthorn (Semester 1, Semester 2)

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
  • 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.

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New Program Structure - effective from 2010: 
The Graduate Certificate of Science (Good Manufacturing Practices) is the first stage in a nested suite of postgraduate programs including the Graduate Diploma of Science (Good Manufacturing Practices), Master of Science (Good Manufacturing Practices) and the Master of Science (Good Manufacturing Practices and Quality Management). Students undertaking the graduate certificate must complete a total of four units of study (totalling 50 credit points), normally over six months (full-time) or one year (part-time) 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, D or E)
Flexible and block mode delivery may alter time frames but not credit point requirements. Students must undertake four prescribed units of study (50 cp).
 
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.

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Units of Study for New Program Structure - effective from 2010:
 
 
*Only available at the Hawthorn campus

Notes:
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.
 
Staff from Seer Pharma Pty Ltd teach units in this program.

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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, and the
  • ability to work independently

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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 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.

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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 program 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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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.

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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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