Lisa is an active member of the PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter. Lisa's experience comes from a background in Forensic & Analytical Chemistry, accompanied by a Masters in Forensic Science. 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 Fill and Finish, QA, Release for supply and auditing. The majority of her time in the industry has been in roles working within the CSL group which manufactures biological products such as vaccines, antivenoms and blood products.

Justine is Chief Executive Officer at CBE Pure Solutions, Contract Manufacturing and testing services in Melbourne.

Justine is also a former Director of CBE, Centre of Biopharmaceutical Excellence, leading consulting firm providing service to Biopharmaceutical Industry in the areas of strategy, operations, compliance, training, regulatory & clinical support and facility design.

As a senior leader with extensive technical and management experience in Quality and Manufacturing in the Pharmaceutical, Biotechnology and Medical Device industries, Justine has worked on assignments in USA, Europe and Asia over a career span over 25 years.

Formally, a Senior Director of Quality Operations for ANZ and India at Hospira Corp. Pty Ltd and Pfizer Corp. Pty Ltd, Justine has had responsibility for providing technical, operational and strategic leadership to ensure site compliance in accordance with US FDA, EU-TGA-PIC/s regulations and local and international standards. Justine has particular expertise in Microbiology, environmental monitoring and aseptic processing compliance.

Justine is a registered auditor for the Australian Pesticides and Veterinary Manufacturing Authority (APVMA) on behalf of the Australian government, a technical assessor for National Association of Authorities (NATA) and current President for the PDA, Australian chapter

Mylinh is currently the Senior Lab Manager within the CSIRO's National Vaccine and Therapeutics Laboratory with over 20 years of experience working in both the academic research environment and the Biotech industry (Murex Biotech, Abbott Laboratory). Mylinh gained her Ph.D at the University of Melbourne (Department of Pharmacology), she is also an Alexander Von Humboldt Fellow, and a Research Fellow at the William Harvey Research Institution (University of London, UK), and an honorary senior lecturer in immunopharmacology. Mylinh areas of expertise and interests include large scale manufacture of monoclonal and recombinant protein using single use bioreactor, she also spent several years within the Supply Chain Management team at Murex Biotech and had first-hand experience with Lean Six Sigma for process improvement. 

She later moved to CSIRO and helped to establish the CSIRO Tissue Culture Facility and more recently was involved in the design/ establishment/ qualification of a new manufacture clean room suites, CSIRO's new National Vaccine and Therapeutics Laboratory. Mylinh current interests are Environmental Monitoring; Contamination Control Strategy; Equipment and Process Validations and Phase Appropriate Manufacturing.    

Mylinh is a committee member of the Parenteral Drug Association (PDA), Australian Chapter since 2018.

Dr. Peter Qiu is the External Advocacy Lead for Asia Pacific at Roche Genentech with over 13 years of experience working with the US FDA. He was the Division Director in the Division of Biotechnology Manufacturing, Office of Pharmaceutical Manufacturing Assessment, CDER. He led the assessment of manufacturing processes, facilities, and microbiological control for CDER's Biologics License Application review and inspection program.

Dr. Qiu has extensive knowledge in microbial controls and sterility assurance assessment as well as in pre-license and pre-approval inspections for biotech products.

Dr. Qiu graduated from the University of Southern California with a Ph.D. in Biological Sciences.

Dr. Hue Kwon has been advising and consulting internationally as a senior advisor consultant on GxP quality maturity and digital transformation for various pharma/biotech organizations. She has over 20 years of experience in GxP quality and regulatory strategies from working within the biopharmaceutical industry including being a Vice President and Quality Team Leader at Samsung Bioepis providing GxP quality and compliance oversight for the end-to-end drug development and lifecycle and being the Head of Business Management and Head of Quality and Compliance in Roche, as a member of a senior management team and leading international GxP capability building and interaction with foreign regulatory agencies to influence in the decision making and building consensus.

Until December 2010, she served at US FDA for about 9 years on the development of regulatory guidance, emerging regulatory strategy and review and data integrity inspections.