PDA Australia Chapter
Chapter's Region:
Australia / New Zealand
Welcome to the PDA Australia Chapter.
We are a part of a respected international community of scientists leading the way in the advancement of pharmaceutical technology. Connecting people, science and regulation is PDA's global mission.
PDA membership will allow you to:
- Connect with other members via PDA Conferences and PDA Connect®
- Access to the latest research and news
- Attend Australian PDA Chapter events at a discount to the non- member price
- Interact with industry leaders and representatives from global regulatory agencies
- Increase your scientific and regulatory knowledge
To be added to the mailing list for notification of future events, please contact the Chapter President or any member of the PDA Australia Chapter Committee.
Current PDA members can also join us at our PDA Connect® page.
Committee Members
- Mark Dickson, CSL Behring
- Gerry McKiernan, Cell Therapies Pty Ltd.
- David Spaulding, Seerpharma Pty Ltd.
- Paul Kerr, SeerPharma Pty. Ltd.
Member at Large
- Jeremy Anderson
- Lisa Bennett
- Mark Dickson
- Usha Gullapalli
- Melissa Khouri
- Gerry McKiernan
- Fergus O'Connell
- Nadia Seidel
- Craig Stephens
Chapter Events
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8 May
PDA Australia Chapter: Dinner and Networking Event and Discussion
- 08 May 2024
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13 Jun
PDA Australia Chapter: Networking Event
- 13 Jun 2024
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25 Jul
PDA Australia Chapter: Summer Networking Event
- 25 Jul 2024
- Melbourne
- , Australia
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14 Oct
PDA Australia Chapter: PDA APAC and PDA Australia Chapter Aseptic Manufacturing Excellence Conference
- 14 Oct - 16 Oct 2024
- Melbourne
- , Australia
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
The PDA Australia Committee is delighted to announce that we have set up a Students and Young Professionals (SYP) part of the PDA Australia Chapter.
The mission of the PDA Australia SYP shall be:
- To develop future leaders in the applied life sciences.
- To establish a culture of life-long learning and professional development.
- To foster stronger relationships between students/young professionals and pharmaceutical and biotechnology professionals.
- To exemplify the purpose of PDA including promoting the sciences of pharmaceutical technology and high standards for products of the pharmaceutical industry with emphasis on parenteral technology, sterile products, and related processes.
We are thrilled to have the following people in SYP mission-control and will be fully supported by the PDA Australia Chapter:
Student Chapter Officers
Student Chapter President
Pauline Deng
Pauline graduated from the University of Western Australia, majoring in Biochemistry and Molecular Biology, and completed her Honours in Pharmacology. She is an alumni of the CSL Graduate program and currently working in Global Pharmacovigilance for CSL. Pauline has held previous roles in Quality Assurance, continuous improvement, and project management. She enjoys continuously learning within the different areas of the pharmaceutical industry and is very passionate about advocating opportunities for the next generation of STEM leaders!
Student Chapter President-Elect
Adam Alhuwaider
Adi is currently a Senior Research Assistant at St. Vincent’s Institute of Medical Research in the Recombinant DNA Repair group, working on a collaborative oncology project with Pfizer’s Centre of Therapeutic Innovation. He has joined the pharmaceutical industry at CSL shortly after finishing his Ph.D. in Biochemistry, specifically protein function in health and disease. His studies and technical skills have provided the background needed for the scale-up development work in R&D for the different CSL drug products, and in medical research. Adi is keen to develop and learn about various aspects of the pharmaceutical industry, starting from Drug Design and Development, to Quality Control and Quality Assurance.
Student Chapter Immediate Past President
Selda Yildiz-Kaya
Selda has around 9 years of experience in working for some of the largest pharmaceutical companies in Turkey and Australia. Selda is currently working as a Senior Quality Assurance and Compliance Associate at CSL Behring in Melbourne and assisting with Regulatory Inspections. She has had various roles within Engineering and Quality departments previously. Selda is a Chemical Engineer and has a Master’s Degree in Business Administration. She is passionate about any learning experience that offers a different perspective and promotes continuous improvement at workplace.
Student Chapter Treasurer
Rebecca Seneviratna
Rebecca is currently a research scientist at the Peter Doherty Institute for Infection and Immunity in the Godfrey laboratory, where she investigates the development and function of unconventional T cells in diseases such as Merkle cell carcinoma, prostate cancer, malaria and more recently, COVID-19. Rebecca is a science honours graduate and qualified Australian lawyer, who prior to working in academia, was a senior project officer for the federal government and a junior lawyer. Rebecca is very interested in the intersection between academic research and industry and has been selected to participate in The BridgeTech Program 2022.
PDA Australia Student Chapter "FInd Your Future In STEM" Photos
(l-r) Shauna Herbst, Bonnie Seymour, Srujana Mokka, Selda Yildiz Kaya (SYP President), Pauline Deng (SYP Vice President) and Polly Sabljak
(l-r) Adi Alhuwaider (SYP Treasurer) and Charlie Ma (SYP Secretary)Chapter Officers
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Justine Mann
President
CBE
Justine Mann is a Director 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, PhDPresident-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 SchafferiusSecretary
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 Sherriff
Treasurer
SeerPharma Pty. Ltd.
Jo, currently a Senior GMP Consultant at SeerPharma Pty Ltd, is an experienced senior compliance engineer 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
- Annual Product Review Developing an SOP
- Data Integrity - Success by Design
- Ethylene Oxide & Gamma Sterilisation Trials and Tribulations 18 September 2012 Presentation Three
- Ethylene Oxide & Gamma Sterilisation Trials and Tribulations 18 September 2012 Presentation Two
- Supplier Qualification - Industry and Regulator Perspective
- Cleanroom Myths
- Facility Operation - Evolution, Not Revolution
- PUPSIT
- FDAs Process Validation Guidance 12 May 2011 - Presentation One
- Cross-Contamination Control, Facility Design
- Cold Chain 101 The First Steps
- The foundations for Single-Use Manufacturing
- Good Distribution Practices & the Value of Data
- Toxic Material Handling
- Contamination Control Cleaning Validation
- Compliance Issues around Data Integrity; Data Management
- FDAs Process Validation Guidance 12 May 2011 - Presentation Three
- A Risky Night - Risk Management, Presentation Two 21 April 2009
- Quality Metrics
- Managing High Value Pharma Shipments with Innovative Collaboration Between Multiple Stakeholders
- GMP Challanges in Cell Therapy Products
- Decontamination with H2O2 for aseptic Isolators
- FDAs Process Validation Guidance 12 May 2011 - Presentation Two
- Cold Chain Event Opening Presentation
- Single Use Systems 20 March 2012 - Presentation One
- CSL Behring Presentation
- Single Use Systems 20 March 2012 - Presentation Two
- Data Integrity Audits - Pitfalls, Expectations & Experiences
- Data Integrity and Quality Culture Webinar - Host Presentation
- Cold Chain Custody Quality Aspects
- Biofilm generation and remediation
- Media Fills and Environmental Monitoring 26 July 2011 - Presentation One
- 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
- Ethylene Oxide & Gamma Sterilisation Trials and Tribulations 18 September 2012 Presentation Four
- 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
- TGA 2015 Achievements & Challenges
- T-cells and Cancer, New Therapies
- PUPSIT
- Aseptic Processing
- Data Integrity and the Cloud
- Preventing of Cross Contamination
- Supplier Cooperation - What is Our Point of Difference in Australia
- Validation of Sterilising and Virally Retentive Filters
- A Risk Based Cleaning and Disinfection Program
- A Risky Night - Risk Management, Presentation One, 21 April 2009
- PDA Points to Consider in Aseptic Processing
- Data Integrity - Focus on Microbiological Testing Challenges
- Regulatory Inspections - Preparation, Execution and Deriving Value
- Media Fills and Environmental Monitoring 26 July 2011 - Presentation Three
- Media Fills and Environmental Monitoring 26 July 2011 - Presentation Two
- Single Use Systems 20 March 2012 - Presentation Four
- Quality by Design (QbD) Overview
- Current Issues in Aseptic Processing
- 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
- Work Practice Change and Leadership
- Data Integrity - Focus on Quality Culture
- CAPA Investigations -Reignite your passion for quality investigations
- Single Use Systems 20 March 2012 - Presentation Three
- Update to the Manufacturing Principles for Medicinal Products
- Enabling Improvement through the Product Lifecycle Change Management within a PQS
- FDA-EMA Aseptic Requirements Annex 1
- Current Debates and Challenges in Disinfectant Validation & Method
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