Online Good Manufacturing Practice Postgraduate Qualifications - Graduate Certificate in GMP - SeerPharma
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Online Good Manufacturing Practice Postgraduate Qualifications Graduate Certificate in GMP
Introduction Choose an industry-integrated qualification with the the Graduate Certificate in Good Manufacturing Practice (GMP). This program is the result of a partnership between The Graduate School of Health at the University of Technology Sydney (UTS) and SeerPharma, a leading industry provider of technical compliance and quality assurance knowledge in the Asia Pacific region. This collaborative foundation means you’ll study curriculum that’s both professionally relevant and informed by stringent industry standards. You’ll gain critical knowledge of regulations, compliance, development and quality assurance, as well as an in-depth understanding of quality and good manufacturing practice to meet FDA, TGA, PIC/S and WHO requirements. You’ll also learn about legislative issues impacting licensed therapeutic goods; related Good Practices (GxP) and Quality Management Systems (QMS) compliance; risk management; and quality management, assurance and control – all important components of a GMP career. Why UTS: At the Graduate School Health our students come first. Our academic leaders, professional partners and educational design team have created a suite of courses with you – and your future career – in mind. Research-inspired curriculum, and best practice educational pedagogy inspire everything we do. The UTS Model of Learning is all about you. It’s focused on producing inspired, inspiring and work- ready graduates who’ll shape the future of the health professions. Our model: delivers practice-oriented, global and research-inspired learning combines digital and face-to-face learning opportunities and resources links theoretical knowledge to practical application encourages collaborative, enquiry based learning activities, including guest lectures produces work-ready graduates who are competitive and well connected stimulates life-long learning Why SeerPharma: SeerPharma Pty Ltd is the industry’s leading provider of technical compliance and Quality Assurance knowledge and expert training to the pharmaceutical, medical device and biotechnology healthcare industry sectors in Australia and the Asia-Pacific region. For over 25 years, SeerPharma has trained over 4000 students and 200 companies throughout Australia, India, Korea, Malaysia, New Zealand, Singapore, Thailand, United Kingdom and Vietnam. SeerPharma offers a comprehensive range of consulting services and specialist expertise to pharmaceutical, medical device and life science companies and has built a strong reputation for supporting companies and products in development through to commercial manufacture.
Learn from the Best
Dr Kamal Dua, Coordinator (GMP Programs), Graduate School of
Health, UTS
Dr. Kamal Dua holds a doctoral degree in Pharmaceutical Sciences, MPharm,
BPharm and four professional diplomas in Clinical Research, Drug Regulatory
Affairs and Documentation, Product Development and Intellectual Property
Rights. Dr. Dua’s professional experience spans 13 years in academia and
research across 3 nations and 2 continents. He has developed and
implemented both traditional and flexible student centred, innovative and
engaging teaching modes that include e-learning and blended learning. Dr. Dua is currently a
lecturer with the Graduate School of Health (Pharmacy), UTS. His responsibilities include
coordinating the academic and research activities associated with Master of GMP course.
Jacqueline Berry, Lecturer and Consultant, SeerPharma
Jacqueline brings her knowledge of pharmaceutical manufacturing and quality
systems to share with students in collaborative classroom sessions. Spanning
20-plus years, Jacqueline’s experience in the industry encompasses QMS
development, GxP auditing, solid dose and liquid manufacture, validation,
stability studies and other GMP and quality related activities. This broad
experience means that classroom sessions are enriched with personal
anecdotes and first-hand knowledge. In addition to teaching the Master of GMP course, Jacqueline
also conducts industry training and provides consulting services to the pharmaceutical industry.
Dr Rick Ng, Lecturer, SeerPharma
Dr Rick Ng has a PhD degree in Chemistry and an MBA degree in international
business. He has held several senior positions in research, quality assurance /
control and regulatory affairs in the biotech and pharmaceutical industry in
Australia and Singapore for more than 30 years. Rick has also provided training
and consulting services to pharmaceutical organisations on GMP compliance
and regulatory matters. He has lectured at the National University of Singapore
and University of NSW.
He is the author of a best-selling pharmacology product development book – Drugs: From
Discovery to Approval published by Wiley.
Course Structure Four subjects in total are studied to complete the Graduate Certificate course. For a part time study load, students typically study two subjects per semester. All students must study “International GMPs and Quality Assurance” and choose three other subjects from those listed below; note that additional subject choices are becoming available from 2020. Autumn Semester (Study commences late February each year) International GMPs and Quality Assurance – Core subject This subject provides an introduction to GMP, with a focus on international aspects and QA. It covers the fundamental requirements for GMP in the manufacture of human or veterinary therapeutic products and critical QA systems such as change control, deviations, documentation, corrective and preventive action, recalls and post market monitoring requirements, including understanding how these are integrated into a company’s overall quality system. GMP for Manufacturing Operations This subject provides an overview of manufacturing and packaging operations, risk management, risk assessment and their application in improving decision making processes and optimising GMP compliance. The subject explores the roles and responsibilities of managers and supervisors in a pharmaceutical manufacturing environment. The contribution of systematic competency-based training is examined. Validation Principles and Practices In this subject validation principles for GMP are introduced, and students examine the validation requirements of various pharmaceutical regulatory bodies and international organisations. Students extend the principles of validation to practical outcomes encompassing workshops in preparing validation protocols from planning, through equipment qualification to process validation, evaluation of validation results and how to conduct cleaning validation. Good (Quality Control) Laboratory Practices This subject aims to introduce good (quality control) laboratory practices for laboratory analysts and supervisors who are involved in regulated laboratories. The subject explores the fundamentals of, and the quality systems in place within, a regulated laboratory.
Course Structure Continued Spring Semester (Study commences late July each year) GxP and Quality Auditing Practices This subject gives students an advanced understanding of quality auditing practices and is relevant to all disciplines of GxP. This subject provides students with knowledge, and practical skills in auditing principles and practices. It also develops practical skills in planning, conducting and reporting quality audits applicable to the manufacturing of medicines and medical devices. Risk Management for Pharmaceutical Operations This subject introduces the key principles and functions of compliance for an organisation, describes what a compliance program consists of and how to set up a company program. The subject introduces the key principles and risk models for the introduction of a risk management program into regulated life sciences organisations. The subject also provides guidance on how risk management practices are used to support compliance programs. Good Aseptic Practices and Sterile Products (from 2020) This subject gives students an advanced understanding of good aseptic practices and is relevant to cleanroom and aseptic managers and supervisors. The subject teaches participants to identify risk situations that may impact sterility assurance. The subject is case-study oriented where students investigate industry situations. Contamination Control (from 2021) This subject explores the principles and requirements for contamination control. It identifies the different types of contamination and potential sources of contamination, introduces risk assessment methodologies that can be used to analyse the major risks to products, and looks at how to develop strategies for contamination control.
Online Learning Online learning is a practical option for students unable to attend campus due to work commitments or distance. There are no fixed class times, students study when it suits them. Studying online does not mean that the student is isolated from the teacher or from the learning community. A variety of strategies are used to provide an environment for learning and to foster student-student collaboration. In this course students will learn through online content comprising videos, set reading, directed research, activities and self-check quizzes. This independent learning will be supported by group learning experiences using online discussions, in which ideas and concepts can be tested and refined. In addition, online students will have regular access to the class teacher via online ‘open office’ hours. Assessment is conducted throughout the semester and comprises tasks such as contribution to online discussions, written and/or oral reports, group projects, presentations via online conferencing and written exams. Each subject is structured as a number of modules that typically cover a two-week period. Materials are made available on ‘Canvas’, UTS’ online learning system. Canvas can be accessed from your computer, tablet or mobile device, so you can learn anywhere, anytime. Each subject in this course will require approximately 3-6 hours per week of study. Time will vary depending on student familiarity with the subject matter. Additional time may be needed to complete assessments.
Fees
Fees cover the entire course of four subjects and include online learning materials, support from your
lecturer and assessment activities. For up to date fee information please use the UTS fee calculator at
https://cis.uts.edu.au/fees/course-fees.cfm and the following guidance:
You are considered to be a domestic student if you are an:
Australian or New Zealand citizen
Holder of an Australian permanent resident visa
Eligible domestic students can apply for FEE-HELP to support studies in this course.
International students may not be eligible for an Australian student visa if studying online.
Fee type: select domestic or international postgraduate coursework
Fee year: and Cohort year: select as appropriate
Course area: select Health (GEM)
Course code or name: enter C11249
Click "Search"
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.
UTS English Language requirements also apply.How to Apply
Ready to apply, or have questions about the UTS application process?
Apply now
Call UTS: +61-2-9514-1448
Email: gsh.future@uts.edu.au
Application Closing Date
Applications close approximately 2 months prior to commencement date for international students
and approximately 1 month prior to the commencement date for domestic students. Contact
gsh.future@uts.edu.au for specific information.
After successfully completing this course of study, students will be awarded the Graduate Certificate
in Good Manufacturing Practice issued by the University of Technology Sydney.
Need More Information?
Find out more
Please contact Jacqueline Berry or Kamal Dua if you have any questions about how online learning
works, course content or any other information you may need to help you assess the suitability of the
course for your requirements.
Jacqueline Berry Kamal Dua
Lecturer/Consultant Course Coordinator, GMP
SeerPharma Pty Ltd Discipline of Pharmacy
www.seerpharma.com Graduate School of Health
Mob: +61 (0)434 075 429 University of Technology Sydney
Email: jacqueline@seerpharma.com.au Phone: +61 (02) 9514 7387
Email: Kamal.Dua@uts.edu.auYou can also read
