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Good Manufacturing
Practice (GMP)
Graduate School of Health
gsh.uts.edu.au
Postgraduate
courses at UTS
UTS CRICOS 00099F
A few notes..
• Q & A
• Presentation Slides
Tonight’s presenters
Dr Kamal Dua
Course Coordinator and Senior Lecturer
Good Manufacturing Practice
Good Manufacturing Practice Information Session
Hala Al-wattar
Lecturer (GMP) and Consultant (SeerPharma)
Good Manufacturing Practice
Presentation Agenda
• About the UTS Master of GMP
• Why UTS?
• What will I study?
• Career opportunities
• Student successes
• Scholarships
• Pre-requisites
• How to apply
Followed by Q&A
Rated #1
Young
University in
Australia*
*QS Top 50 under 50 2021
Our partnership with SeerPharma
Who is this
program
designed for ?
.
Multiple
career
options
Why study Good Manufacturing
Practice at UTS?
Unique to UTS
Exclusive
skill set
The Good Manufacturing Practice team
Professor Kylie Williams (Head of Discipline)
Dr Kamal Dua (Course Coordinator)
David Spaulding, Senior Consultant and Training Manager, SeerPharma
Ian Lucas, Senior Consultant and Training Manager, SeerPharma
Dr Rick Ng, Lecturer
Jacqueline Berry, Lecturer & Consultant
Hala Alwattar, Lecturer & Consultant
Associates of the Graduate School of Health
Dr Michael John Rathbone
Dr Aniss Chami
David Campbell
Humberto Zardo
Dr Sajjad Khan
Dr Amit Gupta
Programs Load credit points
Master of Good Manufacturing Practice (MGMP) 96
Graduate Diploma in Good Manufacturing Practice (GradDipGMP) 48
Graduate Certificate in Good Manufacturing Practice (GradCertGMP) 24
Intakes
• Calendar B Autumn session (Feb – June)
• Calendar B Spring session (Jul – Dec)
Program Information
YEAR | SESSION SUBJECT
Year 1
Calendar B Autumn Session
• GMP for Manufacturing Operations
• Validation Principles and Practices
• International GMPs and Quality Assurance
• Good (Quality Control) Laboratory Practices
Calendar B Spring Session
• Contamination Control
• Good Aseptic Practices and Sterile Products
• GxP and Quality Auditing Practices
• Risk Management for Pharmaceutical Operations
Year 2
Calendar B Autumn Session
• Process Development for Therapeutics: A Perspective for
Finished Dose Forms
• Clinical Trials Quality Assurance Management
• Supply Chain Management
• Industrial Research Project A
Calendar B Spring Session
• Computer Systems Validation Principles and Practices
• Medical Devices: Regulatory and Quality Systems
Requirements
• Biotech Manufacturing
• Industrial Research Project B
Course Outline
UTS CRICOS 00099F
Expectation for student
independent study
each week prior to
class
.
Collaborative learning in
a classroom
environment
Assessments include,
written exams, group
projects, reports,
presentations…
Access to the class
teacher also
available outside of
class time
Subject structure
3 hours of personal
study
3hours of classwork
per week
Campus attendance 2
days per week
On Campus
learning
UTS CRICOS 00099F
Practical option for
students unable to
attend due to work
commitments
.
Independent learning in
conjunction with an
online environment to
foster collaboration
Assessments
via online conferencing,
written exams, group
projects…
Regular access to
the class teacher
Subject structure
3-6 hours of
study/week
100% online
Distance
learning
Careerprospects
z
Consultancy
z
Clinical
Trials
z
Laboratory
Staff
z
Stability
Studies
z
Validation
z
Regulatory
FDA
TGA
• Auditor in government agencies
• Regulatory affairs manager/associate
z
Higher
Education
z
Pharmaceutical, medical
device or biotechnology
industries
z
• Regulatory Compliance
• Documentation
• Supply Chain
• Industrial Pharmacist
z
• Production Management
• Quality Control
• Quality Assurance
• Supply Chain Manager
Student success
My story
EMO Quality Associate
ANZ (Health) at Reckitt
Benckiser
Maria Pearce
Bachelor's in Pharmacy
MBA in Project Management
Master of GMP
My story
Alejandro Silagan
Master of GMP
Head of Quality and
Operations at CGS Pharma
My story
Curtis Twumasi-
Danquah
Bachelor’s of Chemistry
Master of GMP
Current Second year
student
My story
James Ogilvie
Master of GMP
Regulatory Affairs Associate
at Complementary
Medicines Group (CMG)
UTS CRICOS 00099F
Course pre-requisites
• pharmacy and pharmaceutical sciences
• chemistry
• biotechnology and bioinformatics
• microbiology
• food technology, cosmetics, and nutraceutical
• science or medical science
• engineering and related technologies
UTS CRICOS 00099F
Required documentation
• Official academic transcript as recognised by UTS,
or an equivalent or higher qualification
• Satisfactory course pre-requisites in the last 10
years
• Meet English language requirements
• CV / work experience
UTS CRICOS 00099F
Scholarships
UTS Health Postgraduate Academic Excellence Scholarship
25% or 35% of UTS tuition fees for the course
International Postgraduate Coursework Full Tuition Scholarship
Full tuition fees for standard duration of UTS postgraduate degree
Australia Awards Scholarships
Opportunities for people from developing countries, particularly from the Indo-
Pacific region, to undertake full time undergraduate or postgraduate study
Onshore Postgraduate International Scholarship
25% of UTS tuition fees for the course
LATAM international postgraduate coursework scholarship
25% of UTS tuition fees for the course
Grant for Masters by Coursework
$3,000 towards the first session tuition fees
Lindsay Croft Postgraduate Memorial Scholarship
$5,000 towards UTS tuition fees
The SeerPharma Scholarship
$2000 - $8000 towards UTS tuition fees for the course
How much will it cost?
• Visit the UTS Fee Calculator: uts.edu.au/tuition-fee-calculator
• Click ‘Search fees by course’ for domestic-fee paying and
international students
• Follow the prompts
• Fee type: Postgraduate Domestic Coursework or
International Domestic Coursework
• Fee year: 2023
• Cohort year: 2023
• Course area: Health (GEM)
• Course code/name: Good Manufacturing Practice
• Click ‘Search’
• Costs are displayed per credit point and per session
(session calculated as a full-time load of 4 subjects)
Fees
fees.uts.edu.au
Master of Good Manufacturing Practice
Is there fee
support available?
 Government loan scheme for tuition fees for
domestic students
 You do not pay fees upfront - inform your employer
you have a FEE-HELP loan and they will withhold
your payments through the PAYG tax system
 Compulsory repayments proportionate to income.
 Tuition fees may be tax deductible if related to your
employment - contact your financial advisor or the
ATO www.ato.gov.au
 For further information see the Australian
Government Study Assist website:
http://studyassist.gov.au
FEE-HELP
studyassist.gov.au
Master of Good Manufacturing Practice
How to apply
International students
Must submit an application
via UTS international
www.uts.edu.au/future-
students/international
Apply directly to UTS
(no application fee)
uts.edu.au/gmp-apply
z
Applications
for Autumn are
OPEN
Domestic students
Course fee
assistance
FEE-HELP is a loan
scheme that assists eligible
domestic fee-paying
students.
Full details are available at
studyassist.gov.au
gsh.future@uts.edu.au
international@uts.edu.au
z
Autumn International
application
closing dates
International applications
based outside Australia
30 November 2022
International applications
based in Australia
15 December 2022
z
Applications
for Autumn are
OPEN
UTS CRICOS 00099F
Questions?
For questions and enquiries,
contact us via
gsh.future@uts.edu.au
Follow UTS Graduate School of
Health on social media
Facebook, LinkedIn, Twitter
Thanks for
joining us

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UTS Good Manufacturing Practice Information Session

  • 1. Good Manufacturing Practice (GMP) Graduate School of Health gsh.uts.edu.au Postgraduate courses at UTS
  • 2. UTS CRICOS 00099F A few notes.. • Q & A • Presentation Slides
  • 3. Tonight’s presenters Dr Kamal Dua Course Coordinator and Senior Lecturer Good Manufacturing Practice Good Manufacturing Practice Information Session Hala Al-wattar Lecturer (GMP) and Consultant (SeerPharma) Good Manufacturing Practice
  • 4. Presentation Agenda • About the UTS Master of GMP • Why UTS? • What will I study? • Career opportunities • Student successes • Scholarships • Pre-requisites • How to apply Followed by Q&A Rated #1 Young University in Australia* *QS Top 50 under 50 2021
  • 5. Our partnership with SeerPharma
  • 6. Who is this program designed for ? . Multiple career options Why study Good Manufacturing Practice at UTS? Unique to UTS Exclusive skill set
  • 7. The Good Manufacturing Practice team Professor Kylie Williams (Head of Discipline) Dr Kamal Dua (Course Coordinator) David Spaulding, Senior Consultant and Training Manager, SeerPharma Ian Lucas, Senior Consultant and Training Manager, SeerPharma Dr Rick Ng, Lecturer Jacqueline Berry, Lecturer & Consultant Hala Alwattar, Lecturer & Consultant Associates of the Graduate School of Health Dr Michael John Rathbone Dr Aniss Chami David Campbell Humberto Zardo Dr Sajjad Khan Dr Amit Gupta
  • 8. Programs Load credit points Master of Good Manufacturing Practice (MGMP) 96 Graduate Diploma in Good Manufacturing Practice (GradDipGMP) 48 Graduate Certificate in Good Manufacturing Practice (GradCertGMP) 24 Intakes • Calendar B Autumn session (Feb – June) • Calendar B Spring session (Jul – Dec) Program Information
  • 9. YEAR | SESSION SUBJECT Year 1 Calendar B Autumn Session • GMP for Manufacturing Operations • Validation Principles and Practices • International GMPs and Quality Assurance • Good (Quality Control) Laboratory Practices Calendar B Spring Session • Contamination Control • Good Aseptic Practices and Sterile Products • GxP and Quality Auditing Practices • Risk Management for Pharmaceutical Operations Year 2 Calendar B Autumn Session • Process Development for Therapeutics: A Perspective for Finished Dose Forms • Clinical Trials Quality Assurance Management • Supply Chain Management • Industrial Research Project A Calendar B Spring Session • Computer Systems Validation Principles and Practices • Medical Devices: Regulatory and Quality Systems Requirements • Biotech Manufacturing • Industrial Research Project B Course Outline
  • 10. UTS CRICOS 00099F Expectation for student independent study each week prior to class . Collaborative learning in a classroom environment Assessments include, written exams, group projects, reports, presentations… Access to the class teacher also available outside of class time Subject structure 3 hours of personal study 3hours of classwork per week Campus attendance 2 days per week On Campus learning
  • 11. UTS CRICOS 00099F Practical option for students unable to attend due to work commitments . Independent learning in conjunction with an online environment to foster collaboration Assessments via online conferencing, written exams, group projects… Regular access to the class teacher Subject structure 3-6 hours of study/week 100% online Distance learning
  • 12. Careerprospects z Consultancy z Clinical Trials z Laboratory Staff z Stability Studies z Validation z Regulatory FDA TGA • Auditor in government agencies • Regulatory affairs manager/associate z Higher Education z Pharmaceutical, medical device or biotechnology industries z • Regulatory Compliance • Documentation • Supply Chain • Industrial Pharmacist z • Production Management • Quality Control • Quality Assurance • Supply Chain Manager
  • 14. My story EMO Quality Associate ANZ (Health) at Reckitt Benckiser Maria Pearce Bachelor's in Pharmacy MBA in Project Management Master of GMP
  • 15. My story Alejandro Silagan Master of GMP Head of Quality and Operations at CGS Pharma
  • 16. My story Curtis Twumasi- Danquah Bachelor’s of Chemistry Master of GMP Current Second year student
  • 17. My story James Ogilvie Master of GMP Regulatory Affairs Associate at Complementary Medicines Group (CMG)
  • 18. UTS CRICOS 00099F Course pre-requisites • pharmacy and pharmaceutical sciences • chemistry • biotechnology and bioinformatics • microbiology • food technology, cosmetics, and nutraceutical • science or medical science • engineering and related technologies
  • 19. UTS CRICOS 00099F Required documentation • Official academic transcript as recognised by UTS, or an equivalent or higher qualification • Satisfactory course pre-requisites in the last 10 years • Meet English language requirements • CV / work experience
  • 20. UTS CRICOS 00099F Scholarships UTS Health Postgraduate Academic Excellence Scholarship 25% or 35% of UTS tuition fees for the course International Postgraduate Coursework Full Tuition Scholarship Full tuition fees for standard duration of UTS postgraduate degree Australia Awards Scholarships Opportunities for people from developing countries, particularly from the Indo- Pacific region, to undertake full time undergraduate or postgraduate study Onshore Postgraduate International Scholarship 25% of UTS tuition fees for the course LATAM international postgraduate coursework scholarship 25% of UTS tuition fees for the course Grant for Masters by Coursework $3,000 towards the first session tuition fees Lindsay Croft Postgraduate Memorial Scholarship $5,000 towards UTS tuition fees The SeerPharma Scholarship $2000 - $8000 towards UTS tuition fees for the course
  • 21. How much will it cost? • Visit the UTS Fee Calculator: uts.edu.au/tuition-fee-calculator • Click ‘Search fees by course’ for domestic-fee paying and international students • Follow the prompts • Fee type: Postgraduate Domestic Coursework or International Domestic Coursework • Fee year: 2023 • Cohort year: 2023 • Course area: Health (GEM) • Course code/name: Good Manufacturing Practice • Click ‘Search’ • Costs are displayed per credit point and per session (session calculated as a full-time load of 4 subjects) Fees fees.uts.edu.au Master of Good Manufacturing Practice
  • 22. Is there fee support available?  Government loan scheme for tuition fees for domestic students  You do not pay fees upfront - inform your employer you have a FEE-HELP loan and they will withhold your payments through the PAYG tax system  Compulsory repayments proportionate to income.  Tuition fees may be tax deductible if related to your employment - contact your financial advisor or the ATO www.ato.gov.au  For further information see the Australian Government Study Assist website: http://studyassist.gov.au FEE-HELP studyassist.gov.au Master of Good Manufacturing Practice
  • 23. How to apply International students Must submit an application via UTS international www.uts.edu.au/future- students/international Apply directly to UTS (no application fee) uts.edu.au/gmp-apply z Applications for Autumn are OPEN Domestic students Course fee assistance FEE-HELP is a loan scheme that assists eligible domestic fee-paying students. Full details are available at studyassist.gov.au gsh.future@uts.edu.au international@uts.edu.au z Autumn International application closing dates International applications based outside Australia 30 November 2022 International applications based in Australia 15 December 2022 z Applications for Autumn are OPEN
  • 25. For questions and enquiries, contact us via gsh.future@uts.edu.au Follow UTS Graduate School of Health on social media Facebook, LinkedIn, Twitter Thanks for joining us

Editor's Notes

  1. [Start camera] Self introduction - Please introduce yourself and the ASOs Acknowledgement of country: ​"I would like to acknowledge the Gadigal people of the Eora Nation upon whose ancestral lands our City campus now stands. I would also like to pay respect to the Elders both past and present, acknowledging them as the traditional custodians of knowledge for this land"
  2. [SLIDE 2] Before we get started I’d like to bring to your attention that we’ll be recording tonight’s session and by taking part today you give us consent to process any information you may share with us.   Please confirm if you wish to record your session
  3. [SLIDE 3] – Inform audience of Q&A and that they will receive a copy of the presentation slides.
  4. [SLIDE 4 Marketing Lead / Presenters] Introduce, and hand over to presenters. [Self introduction]     Please introduce yourself. Recommend clicking ‘Start camera’ on this slide to give a friendly face to the session. While you are sharing your screen, your face appears in a small box in the corner of screen.
  5. [SLIDE 5 Presenter] Today we are presenting on the following topics:   About the UTS GMP Course Course outline What you will study and learning methods Scholarships Student Successes Student support Prereq’s How to apply Followed by Q&A
  6. Who is the program designed for? Designed for people working in any position within the pharmaceutical, biotechnology & medical devices sectors who are looking to gain in-depth, up-to-date knowledge of regulations, compliance, process development & quality assurance Exclusive skill set Unique in Australia & the Asia-Pacific region, this degree is highly innovative & professionally focused. Designed by leading experts, the courses provide professional development options and career pathways for students at all levels of industry organisations. Multiple career options Career opportunities include consulting, production chemist, quality control, quality assurance, regulatory compliance, documentation, R&D, and supply chain.  Vital work Good manufacturing practice is central to pharmaceutical manufacturing in order to deliver products that meet quality standards & save lives. Unique to UTS This degree is the only course of its kind in the Asia-Pacific region & has been designed by UTS in close collaboration with SeerPharma, the industry’s leading provider of technical compliance & quality assurance knowledge.
  7. Replace with Bo Anjali, Khalil, SHilpa
  8. All fees info is online: fees.uts.edu.au No need to spend much time on this slide. This is merely to let students know where they can go to get an idea of the fee structure of the course. The prompts are the most important part here (so they know which breadcrumbs to follow). Remind students they are getting a copy of the slides so no need to fret about this info right this second.
  9. [SLIDE 6-15] [usual course presentation] Same notes as previous slide – just brining attention to these assistance schemes.
  10. If you are keen to study at UTS I would encourage you to submit your application online tonight.  The process for applying is now completely online. You will need to register on our online portal (if you haven’t already done so) and commence your application. We have staff here tonight to help you with this. After the tour in the plinth room, you can complete your online application. If you are international student you do need to apply online via UTS international.
  11. [Open Q&A box to view questions] We’ll now take some of your questions that you’ve sent through. [After designated session time is over] If you have further questions, please contact us at gsh.future@uts.edu.au. We will also email you the presentation and useful information. Best of luck with your applications. Hope to see you at UTS next year. End session