Frequently Asked Questions
Q. What will I be able to do once I obtain the Graduate Certificate? How useful will it be to my job?
A. This program is an opportunity to ensure that those personnel working in Australia, New Zealand and overseas (who may be customers, suppliers and partners of Australian and New Zealand based and/or owned therapeutic product industries) have a sound understanding of the requirements for GMP management as well as regulatory management. Courses on quality assurance for product and process improvement, manufacturing strategy, pharmaceutical operational and regulatory management would enable you to acquire the required “knowledge base” provided by this GMP graduate certificate program.
Q. How many hours of study a week do I need to devote to each course?
A. A maximum of 10 hours initially should be expected but over time this should reduce to approximately 6-7 hours a week per course (subject). This includes preparation of assignments, web participation etc.
Q. Will there be any need to come to campus during this program?
A. No. Although, if a student would like to sit their final examination on campus rather than at their place of work and if they are in Sydney during examination time then that can be arranged. Otherwise, there are no on-campus components for any of the courses such as workshops or labs.
Q. How do I make contact with the course facilitators or lecturers?
A. Communication is mainly done via the University's WebCTVista system once semester starts as well as via email, phone or fax.
Q. I understand that the GMP program is jointly run by the Engineering and Medical Sciences Faculties of UNSW. What is the reason for this collaboration?
A. Because a comprehensive program in GMP needs to cover: a) current and future operational and regulatory expectations for the manufacture and control of active pharmaceutical ingredients, b) practical interpretation of existing and to be proposed GMP regulations and guidelines, c) cost effective, compliance strategies for facility design, equipment qualification, process validation etc. The collaboration of both faculties aims to achieve this coverage. This program is also used in collaboration with AMC Limited (Australian Manufacturing Centre) which is supported by a Federally funded project called MITA (Manufacturing Innovative Technical Access Program).
Q. Would this program be of interest to most of the personnel in the pharmaceutical industry?
A. Yes. It will be of particular interest to Qualified Persons (Authorised Persons) as well as all technical and managerial staff within the pharmaceutical industry. Also. Increasing numbers of companies are considering a formal training in GMP as part of a technical and professional development plan for their staff.
Q. Do I need to borrow books from the local library?
A. No. All material needed for the courses is supplied. Being a UNSW student you are entitled to full access to UNSW library. Only if a student wants to purchase/borrow any of the recommended readings would necessitate leaving the comfort of their desk and computer. Some readings will be available to download via the web, others provided by the Facilitator or as part of the course material.
Q. What is an academic transcript?
A. A list of all your subjects and grades achieved in your first tertiary qualification, such as a degree or diploma from either a University or a TAFE.
Q. How many subjects (courses) can I do at one time?
A. The choice is up to you. We offer two courses each semester (and there are two semesters in one academic year at UNSW) so students can elect to enrol in one course per semester which will mean they complete the Graduate Certificate in two years or they can do two courses per semester and complete in one year.
The courses offered each semester are semester specific and only offered in that particular semester. For example, MANF8420 Managing Manufacturing Operations is only available to GMP students in Semester 1 of each year.
Any variation to this and students will be advised.
Q. Can this program give me the essential tools and techniques needed for problem-solving and ultimately prevent unplanned “problems”?
A. Yes. It will provide essential training and on-going professional development for all pharmaceutical technical managers, including Qualified Persons (Authorised Persons), consultants/contractors and trainees.
Q. What if I've taken on too much of a study load and need to reduced that load because work is really busy or I have to go overseas on business trips?
A. Students can discontinue without penalties (financial or academic) if they drop a course by the relevant Census date of each semester, that is, 31 March for Semester 1 and 31 August for Semester 2.
If a course is dropped by Week 8 of the semester students will not have a Fail recorded on their record but they will be liable for the fee for that particular course.
After Week 8 of the semester if a course is dropped, both a Fail is recorded and again the fee is charged.
Q. As of 2006, is there a continuing, formalised national training program available in Australia or New Zealand which can qualify a person for the position of Authorised Person?
A. Currently, the Graduate Certificate in GMP offered by UNSW is the only active and formalised national training program.
Q. How beneficial would this GMP program be to me if I decide to work overseas?
A. This program is an excellent career development strategy since it provides the knowledge and experience of value that you can utilise internationally, since it provides the knowledge to meet the requirements for theoretical training in GMP.
Q. Would I be able to gain a wider industrial perspective?
A. Yes. Several case studies will be provided in the courses which would enable you to gain a wider industrial perspective. Also, the interactive learning environment through WebCTVista of UNSW will ensure you “talk and work with” other students who work in other companies resulting in increased networking and benchmarking.
Q. Who will be the facilitators/lecturers?
A. Highly experienced staff from the University and/or industry will provide the strong technical, practical and industrial focus of the program.
Q. Are there discussions and working groups although the program is a distance delivery one?
A. Yes. A significant proportion of the course time will be devoted to group work, where students have the opportunity to put theory into practice. Additionally, discussion periods provide students with an opportunity to obtain answers to their specific questions and concerns. All of these are carried out through the WebCTVista system that you will be introduced to once you enrol to the program.
Q. If I've completed some courses from another program either at UNSW or another university, can I transfer them to the GMP program?
A. Yes, that's possible. We consider this on a case by case basis depending on what the courses are and if they are relevant to the GMP program.
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