C06115v3 Graduate Diploma in Good Manufacturing Practice

University of Technology Sydney

About

The Graduate Diploma in Good Manufacturing Practice provides up-to-date and in-depth good manufacturing practice (GMP) knowledge within the pharmaceutical, biotechnology and medical device industries.

It provides critical knowledge regarding regulations, compliance/GxP, product development and quality assurance within this heavily regulated industry, an essential ingredient for career development.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 48 credit points of study.

Course completion requirements

course credit
96057 GMP for Manufacturing Operations 6cp
96134 Validation Principles and Practices 6cp
96059 International GMPs and Quality Assurance 6cp
96060 Good (Quality Control) Laboratory Practices 6cp
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
Total 48cp

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, Autumn B commencing, full time

Year 1

Autumn B Session

course credit
96057 GMP for Manufacturing Operations 6cp
96134 Validation Principles and Practices 6cp
96059 International GMPs and Quality Assurance 6cp
96060 Good (Quality Control) Laboratory Practices 6cp

Spring B Session

course credit
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

On campus, Spring B commencing, full time

Year 1

Spring B Session

course credit
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

Year 2

Autumn B Session

course credit
96057 GMP for Manufacturing Operations 6cp
96134 Validation Principles and Practices 6cp
96059 International GMPs and Quality Assurance 6cp
96060 Good (Quality Control) Laboratory Practices 6cp

Distance, Autumn B commencing, part time

Year 1

Autumn B Session

course credit
96059 International GMPs and Quality Assurance 6cp
96057 GMP for Manufacturing Operations 6cp

Spring B Session

course credit
96063 GxP and Quality Auditing Practices 6cp
96064 Risk Management for Pharmaceutical Operations 6cp

Year 2

Autumn B Session

course credit
96060 Good (Quality Control) Laboratory Practices 6cp
96134 Validation Principles and Practices 6cp

Spring B Session

course credit
96069 Contamination Control 6cp
96062 Good Aseptic Practices and Sterile Products 6cp

Distance, Spring B commencing, part time

Year 1

Spring B Session

course credit
96064 Risk Management for Pharmaceutical Operations 6cp
96063 GxP and Quality Auditing Practices 6cp

Year 2

Autumn B Session

course credit
96059 International GMPs and Quality Assurance 6cp
96057 GMP for Manufacturing Operations 6cp

Spring B Session

course credit
96069 Contamination Control 6cp
96062 Good Aseptic Practices and Sterile Products 6cp

Year 3

Autumn B Session

course credit
96060 Good (Quality Control) Laboratory Practices 6cp
96134 Validation Principles and Practices 6cp

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.

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.

Local students

Domestic applicants can apply directly or via the Universities Admissions Centre (UAC).

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