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C11249v3 Graduate Certificate in Good Manufacturing Practice

Award(s): Graduate Certificate in Good Manufacturing Practice (GradCertGMP)
UAC code: 940922 (Calendar B Autumn session, Calendar B Autumn session, Calendar B Spring session, Calendar B Spring session)
CRICOS code: 084261F
Commonwealth supported place?: No
Load credit points: 24
Course EFTSL: 0.5
Location: City campus

Notes

This course is only offered if minimum student numbers are met.


Overview
Career options
Course intended learning outcomes
Admission requirements
Course duration and attendance
Course structure
Course completion requirements
Course program
Other information

Overview

The Graduate Certificate in Good Manufacturing Practice provides up-to-date and in-depth good manufacturing practice (GMP) knowledge within the pharmaceutical, biotechnology and medical device industries. The course provides critical knowledge regarding regulations, compliance/GxP, product development and quality assurance within this heavily regulated industry, an essential ingredient for career development or ongoing study.

This being the only course of its kind in the Asia–Pacific region, the UTS: Pharmacy discipline has partnered with SeerPharma, the industry’s leading provider of technical compliance and quality assurance knowledge, to deliver students a practice-based and research-led education.

Designed by leading experts in the field, the course provides professional development options and career pathways for students at all levels of industry organisations. It is ideal for students wishing to commence or enhance their pharmaceutical industry manufacturing career with an industry-recognised qualification.

Career options

Career options include:

  • production, quality assurance, quality control, documentation, validation, supply chain and regulatory compliance in the pharmaceutical, biotechnology and medical device industry
  • monitoring and quality assurance in clinical research organisations
  • auditing in government regulatory agencies, consultancy in consulting firms and managers and practitioners in various other associated companies where good manufacturing practices are required.

Course intended learning outcomes

.001 Demonstrate accurate knowledge of risk management practices and models, and implement and review them in a range of contexts.
.002 Test, audit and review pharmaceuticals manufacturing and distribution processes using appropriate methodologies.
.003 Implement and review process control systems for pharmaceuticals manufacturing.
.004 Demonstrate ethically and legally accountable approaches to pharmaceuticals manufacturing and control.
.005 Evaluate and apply evidence in the delivery of evidence-based solutions.
.006 Produce accurate technical documentation, and communicate effectively and accurately with clients and stakeholders in written or spoken language appropriate to their needs.
.007 Demonstrate respect and value for diverse ways of knowing, being and doing, in particular recognising the diversity of indigenous Australians, while critically reflecting on the impact of ongoing colonisation and its pervasive discourse on their health and wellbeing, and integrating this knowledge into practice.
.008 Contribute as leader and collaborator in the assurance of Good Manufacturing Practice.
.009 Reflect on the knowledge, skills and attributes required for the integration of emerging evidence into practice, promoting the growth of personal and professional learning, and the education of others.
.010 Collaborate effectively with other professions to ensure Good Manufacturing Practice.
.011 Demonstrate knowledge of Good Manufacturing Practice in local, national and global contexts.

Admission requirements

Applicants must have completed a UTS recognised bachelor's degree, or an equivalent or higher qualification, or submitted other evidence of general and professional qualifications that demonstrates potential to pursue graduate studies.

The above qualifications must be in one of the following related disciplines:

  • pharmacy and pharmaceutical sciences
  • chemistry
  • biotechnology and bioinformatics
  • microbiology
  • food technology, cosmetics, and nutraceutical
  • science or medical science
  • engineering and related technologies.

Applicants who do not satisfy the above academic and additional requirements may be considered on the basis of general and professional qualifications that demonstrate potential to pursue graduate studies via submission of a CV.

The English proficiency requirement for international students or local applicants with international qualifications is: Academic IELTS: 6.5 overall with a writing score of 6.0; or TOEFL: paper based: 550-583 overall with TWE of 4.5, internet based: 79-93 overall with a writing score of 21; or AE5: Pass; or PTE: 58-64; or CAE: 176-184.

Eligibility for admission does not guarantee offer of a place.

International students

Visa requirement: To obtain a student visa to study in Australia, international students must enrol full time and on campus. Australian student visa regulations also require international students studying on student visas to complete the course within the standard full-time duration. Students can extend their courses only in exceptional circumstances.

Course duration and attendance

The course can be completed in one session of full-time or one year of part-time on campus study (contact the Graduate School of Health regarding the part-time offering).

Students can also undertake this course by distance in part-time study mode only. Students who choose this option must undertake the course in the sequence as specified in the course program.

International students may not be eligible for an Australian student visa if subjects are undertaken online.

Course structure

Students must complete 24 credit points of study.

Course completion requirements

96059 International GMPs and Quality Assurance 6cp
Select 18 credit points of options: 18cp
96069 Contamination Control6cp 
96057 GMP for Manufacturing Operations6cp 
96060 Good (Quality Control) Laboratory Practices6cp 
96062 Good Aseptic Practices and Sterile Products6cp 
96063 GxP and Quality Auditing Practices6cp 
96064 Risk Management for Pharmaceutical Operations6cp 
96058 Validation Principles6cp 
Total 24cp

Course program

The following examples show typical on campus and online (distance) programs.

On campus, Calendar B Autumn commencing, full time
96059 International GMPs and Quality Assurance   6cp
96057 GMP for Manufacturing Operations   6cp
96060 Good (Quality Control) Laboratory Practices   6cp
96058 Validation Principles   6cp
On campus, Calendar B Autumn commencing, part time
Year 1
Calendar B Autumn session
96059 International GMPs and Quality Assurance   6cp
Select 6 credit points from the following:   6cp
96057 GMP for Manufacturing Operations 6cp  
96060 Good (Quality Control) Laboratory Practices 6cp  
96058 Validation Principles 6cp  
Calendar B Spring session
Select 12 credit points from the following:   12cp
96069 Contamination Control 6cp  
96062 Good Aseptic Practices and Sterile Products 6cp  
96063 GxP and Quality Auditing Practices 6cp  
96064 Risk Management for Pharmaceutical Operations 6cp  
Distance mode, Calendar B Autumn commencing, part time
Year 1
Calendar B Autumn session
96059 International GMPs and Quality Assurance   6cp
96057 GMP for Manufacturing Operations   6cp
Calendar B Spring session
96063 GxP and Quality Auditing Practices   6cp
96064 Risk Management for Pharmaceutical Operations   6cp
Distance mode, Calendar B Spring commencing, part time
Year 1
Calendar B Spring session
96063 GxP and Quality Auditing Practices   6cp
96064 Risk Management for Pharmaceutical Operations   6cp
Year 2
Calendar B Autumn session
96059 International GMPs and Quality Assurance   6cp
96057 GMP for Manufacturing Operations   6cp

Other information

Further information is available from:

Graduate School of Health
telephone +61 2 9514 1448
email gsh.future@uts.edu.au