C11249v4 Graduate Certificate in Good Manufacturing Practice
University of Technology Sydney
About
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 is 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.
Structure
Students must complete 24 credit points of study.
Course completion requirements
| course | credit |
|---|---|
| 96059 International GMPs and Quality Assurance | 6cp |
| Select 18 credit points of options: | 18cp |
| 96069 Contamination Control | |
| 96057 GMP for Manufacturing Operations | |
| 96060 Good (Quality Control) Laboratory Practices | |
| 96062 Good Aseptic Practices and Sterile Products | |
| 96063 GxP and Quality Auditing Practices | |
| 96064 Risk Management for Pharmaceutical Operations | |
| 96134 Validation Principles and Practices | |
| Total | 24cp |
Course program
Typical full-time and part-time course programs for Autumn B and Spring B commencements as well as on campus and distance (online) enrolment are provided below. These show a suggested study sequence. The subjects are offered in either Autumn B or Spring B sessions. Each student's course program depends on the sequence of undertaken subjects.
On campus or distance, Autumn B commencing, full time
Year 1
Autumn B Session
| course | credit |
|---|---|
| 96059 International GMPs and Quality Assurance | 6cp |
| 96057 GMP for Manufacturing Operations | 6cp |
| 96060 Good (Quality Control) Laboratory Practices | 6cp |
| 96134 Validation Principles and Practices | 6cp |
On campus or distance, Autumn B commencing, part time
Year 1
Autumn B Session
| course | credit |
|---|---|
| 96059 International GMPs and Quality Assurance | 6cp |
| Select 6 credit points from the following: | 6cp |
| 96057 GMP for Manufacturing Operations | |
| 96060 Good (Quality Control) Laboratory Practices | |
| 96134 Validation Principles and Practices | |
Spring B Session
| course | credit |
|---|---|
| Select 12 credit points from the following: | 12cp |
| 96069 Contamination Control | |
| 96062 Good Aseptic Practices and Sterile Products | |
| 96063 GxP and Quality Auditing Practices | |
| 96064 Risk Management for Pharmaceutical Operations | |
On campus or distance mode, Spring B commencing, part time
Year 1
Spring B Session
| course | credit |
|---|---|
| Select 12 credit points from the following: | 12cp |
| 96062 Good Aseptic Practices and Sterile Products | |
| 96063 GxP and Quality Auditing Practices | |
| 96064 Risk Management for Pharmaceutical Operations | |
Year 2
Autumn B Session
| course | credit |
|---|---|
| 96059 International GMPs and Quality Assurance | 6cp |
| Select 6 credit points from the following: | 6cp |
| 96057 GMP for Manufacturing Operations | |
| 96060 Good (Quality Control) Laboratory Practices | |
| 96134 Validation Principles and Practices | |
| 96069 Contamination Control | |
Entry 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.
Local students
Domestic applicants can apply directly or via the Universities Admissions Centre (UAC).
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.
International students
International applicants apply via UTS: International.
International applicants, in addition to the above requirements, are required to obtain a police certificate/criminal clearance from every country they have resided in. If a country does not issue police certificates/criminal clearances, applicants are required to complete a Statutory Declaration for Overseas Students.
Institution
