PDA Australia Chapter
Chapter's Region:
Australia / New Zealand
PDA Australia Chapter Mission
The PDA Australian Chapter serves as a leading organisation for professionals in the Australian biopharma industry. Established in 1996, our mission is to connect people, technology, science, and regulation. We actively promote and enhance knowledge within the sciences and technologies, developing programs and other activities to address local and global needs in alignment with PDA’s mission and objectives. Our goal is to expand our reach nationwide, providing extended connectivity information and content to our members.
Membership
Make the most of your membership:
- Access to PDA Letter
- PDA’s Membership magazine covering science, technology and regulation with articles published monthly
- Access to PDA Journal of Pharmaceutical Science and Technology
- Peer reviewed scientific, regulatory and technical papers
- Access to Technical Reports
- Peer reviewed global consensus documents written by subject-matter experts on issues relating challenging technical areas for industry
Members at Large
- Jeremy Anderson, Senior Aseptic Specialist, Pfizer
- Melissa Khouri, Head of Quality, BioCina
- Gerry McKiernan, Director and Principal Consultant, Increment4
- Fergus O'Connell, Head of Quality, Eurofins Biopharma Testing
- Nadia Seidel, Site Operational Excellence Lead, Pfizer
- Craig Stephens, Senior Director Quality, CSL Behring
Chapter Events
Current Chapter Sponsors
Get Involved
The Australian Chapter is an extension of the PDA international non-profit organization. The local Chapter focuses its efforts towards organizing and providing local events targeted at pharmaceutical/biopharmaceutical industry members, especially those involved in the development, manufacturing, quality control, quality assurance, and regulatory affairs.
The Australian Chapter of the PDA is comprised of volunteers from a variety of local industry organizations and is made up of Chapter Officers that comprise of the Executive Committee and Committee Members. The Australian Chapter aims to run one major event with the TGA annually and additional seminars throughout the year. The objective of these events is to provide industry professionals with a venue and platform to converse and exchange information while enjoying presentations from the top industry professionals.
The Australian Chapter aspires to be an integral link in education and is always looking for new volunteers who may assist us in our efforts. Your support, comments, and suggestions are the mechanism to our improved success.
For additional information, please contact the chapter at pdachapteraus@gmail.com.
Student Chapter
As part of the PDA Committee, our mission is to develop the next generation of future leaders in the applied life sciences. We encourage students and young professionals to join the Australian Students and Young Professionals (SYP) committee which is sponsored by the PDA Australia Chapter. This is a great way to help you realize your career ambitions and help foster stronger relationships and mentoring opportunities between students and pharmaceutical and biotechnology professionals. Joining a professional society like PDA is a great way to get you started!
Student & Young Professional President
Adam is a Senior Postdoctoral Scientist, Adjunct Research Fellow and Education Facilitator at Burnet Institute. As a biochemist, and a self-driven scientist with an aptitude to learn, and further development of existing and new skills. He has experience in biochemistry and cell culture.
For more information on becoming a student chapter members, contact Adam Thomas: LinkedIn
Student & Young Professional Liaison
After beginning her career as an analytical chemist in the petrochemical industry, Lisa moved into roles within the Pharmaceutical industry where she gained hands-on experience in a wide breadth of disciplines such as QC, Stability and Clinical Trials, Supply Chain/Logistics, R&D, Aseptic processing and sterile manufacture, QA including Release for Supply and Quality Auditing.
PDA Australia Student Chapter "Find Your Future In STEM" Photos
(l-r) Shauna Herbst, Bonnie Seymour, Srujana Mokka, Selda Yildiz Kaya, Pauline Deng and Polly Sabljak
(l-r) Adi Alhuwaider and Charlie MaChapter Officers
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Justine MannCEO
President
CBE
Justine Mann is CEO at CBE Pty Ltd. Justine has over 20 years of experience in the pharmaceutical industry as a Quality Operations Director and Technical Operations Manager. Justine has had responsibility for providing technical, operational, and strategic leadership to ensure compliance in accordance with US FDA, EU-TGA-PIC/S regulations and local and international standards. Justine specialises in developing strategic quality plans and risk management plans, focusing on remediation strategies, quality enhancements and process improvements for operational efficiency. Combining a Microbiology background with an MBA specialising in business management and leadership, Justine works with clients to provide strategic and compliant solutions. -
Mylinh La, PhDSenior Laboratory Manager
President-Elect
CSIRO
Mylinh's career highlights include diverse roles, from large-scale protein manufacture to Supply Chain Management at Murex Biotech (UK), with firsthand experience in implementing Lean Six Sigma methodologies for process improvement. Joining CSIRO, she was instrumental in the design, establishment, and qualification of new manufacturing clean room suites at CSIRO's cutting-edge National Vaccine and Therapeutics Laboratory — a milestone for Australia's vaccine and therapeutic research capabilities.
Her current focus are on aseptic manufacturing excellence, covering Environmental Monitoring, Contamination Control Strategy, Equipment, Process Validations, and Phase Appropriate Manufacturing. Since 2018, as a committee member of the Parenteral Drug Association (PDA), Australian Chapter, Mylinh actively fosters collaboration, supports education initiatives, and ensures her team stays updated on industry changes, effectively communicating the value of PDA and spreading awareness within her professional community. -
Micheal SchafferiusApplication Specialist
Secretary
Sartorius- Stedim
Micheal has worked in the pharmaceutical and biopharmaceutical industries for more than 15 years. His experience includes roles focused on Filtration, Single-Use Technologies, Quality Assurance, Validation and Sterile Manufacturing with local and international companies. Currently, Micheal is a specialist for filtration and quality at Sartorius Stedim Biotech. -
Jo SherriffEngineering Compliance Manager
Treasurer
SeerPharma Pty. Ltd.
Jo, currently a Engineering Compliance Manager at SeerPharma Pty Ltd, and senior consultant with 20 years of experience within the pharmaceutical and life science industries. She is not only a qualified Chemical Engineer but also a specialist in the development and execution of GMP validation documentation, GMP Design Reviews, and development of Quality Systems. She also has extensive experience with non-GMP facility compliance, TGA, FDA, DAWR Biosecurity), OGTR, ARPANSA, SSBA, and Pharmacy Board of Australia, SHPA, PRASA compliance. Jo is also an experienced presenter of Validation Workshops, GMP Training and conducts Quality Assurance Audits.
Presentations & Resources
- Application of Lean Sigma
- Supplier Qualification - Industry and Regulator Perspective
- Cleanroom Myths
- Facility Operation - Evolution, Not Revolution
- Cross-Contamination Control, Facility Design
- Compliance Issues around Data Integrity; Data Management
- Managing High Value Pharma Shipments with Innovative Collaboration Between Multiple Stakeholders
- GMP Challanges in Cell Therapy Products
- Decontamination with H2O2 for aseptic Isolators
- Cold Chain Event Opening Presentation
- CSL Behring Presentation
- Data Integrity and Quality Culture Webinar - Host Presentation
- Cold Chain Custody Quality Aspects
- Biofilm generation and remediation
- PICS GMP Guide to Annex 1 - Manufacture of Sterile Medicinal Products
- A Look Foward on the Business and Regulatory Trends for the Pharma Biopharma Industry
- The Regulatory Hurdles and Challenges for Post Approval Changes of Legacy (Existing) Products
- Annex 1 Draft Revision- Focus on Facilities, Facilities, Production & Environmental Monitoring
- PDA TR 26 Update Sterilizing Filtration of Liquids Meeting Validation Requirements
- Global Manufacturing Update - Key Issues and Opportunities
- Implementation of QbD for Existing Products - An Example from GSK Australia
- Desktop Audits - Lessons Learned and Ways Forward
- Behavioural GMP and Human Error Reduction
- The External OOS
- Supplier Quality - The Changing Landscape
- Lean Laboratory Implementation - Ivy Leung GSK
- Laboratory Investigations- A Regulatory Perspective
- Isolator Design and Air Handling
- Rouge Formation & Remediation
- Bringing a Cleanroom Online
- Basic Principles of Human Health Risk Assessment
- Business Continuity and the Matrix
- Case Studies in Spores
Chapter Resources
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