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PDA Australia Chapter

Eoin Hanley

President: Eoin Hanley

CSL Behring

Overview

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 ConnectSM
  • 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 ConnectSM page.
 

Thank You to the Current Chapter Sponsors

  • Pall
  • Merck Millipore
  • Seerpharma
  • Synertec

Upcoming Chapter Events

Coming Soon.
 

PDA Signature Events

 

Officers

Executive Committee

President

Eoin Hanley
CSL Behring

President-Elect

Lisa Bennett
Seqirus

Secretary

Maria Mylonas 
PharmOut Pty Ltd 

Treasurer

Paul Kerr
SeerPharma Pty. Ltd.

Members at Large

Usha Gullapalli
Pfizer
Communications and Memberships

Committee Members

Mark Dickson
CSL Behring

Mylinh La 
CSIRO

Justine Mann
CBE Pty Ltd.


Micheal Schafferius
Sartorius-Stedim

Jo Sherriff 
Seerpharma Pty Ltd.

 
Immediate Past President

David Spaulding
SeerPharma Pty. Ltd.

About Us

Eoin Hanley, President 
Eoin is currently a Quality Assurance Compliance Manager with CSL Behring. Eoin has worked in the pharmaceutical & biotech industries in Europe, the USA and Australia/Pacific, with some of the largest companies in the world. He has experience in a variety of roles within Quality, Engineering, Qualification/Validation and consulting. Eoin has worked on a range of products from API's to sterile medicinal products, including blockbuster recombinant proteins. Eoins experience comes from a background in Analytical Chemistry and an MSc. in Pharmaceutical Validation. He also has a passion for keeping up to date with current regulatory and industry trends, as well as the application of lean and operational excellence approaches.

Lisa Bennett, President Elect 
Lisa is currently a Senior Associate in Quality Assurance at Seqirus, the newest member of the CSL Group. Lisa has 8 years’ experience in the pharmaceutical industry and in this short time has grown through a number of roles within Quality Control, Stability, Clinical Trials, R&D, Aseptic Fill & Finish and more recently in Quality Assurance. Lisa’s experience comes from a background in forensic & analytical chemistry accompanied by a Masters in Forensic Science.

David Spaulding, Immediate Past President 
David has over 30 years experience in the pharmaceutical and dental industries, in Research and Development, Logistics Management, Training, Manufacturing (including aerosols, sterile and non-sterile dosage forms) and Sales and Marketing. He has also owned and managed small to medium sized pharmaceutical companies, specialising in delivering substantial growth and technical expertise. David is currently a senior consultant with SeerPharma Pty. Ltd.

Paul Kerr, Treasurer 
Paul is a Partner of SeerPharma and has over 30 years broad pharmaceutical experience across various technological areas (scientific and IT) as a qualified chemist and an IT project manager. Paul is a qualified PDA Software Supplier Auditor and conducts IT gap analysis and compliance audits for companies. Paul is experienced in computer validation and assists companies establish IT compliance and computer validation programs. He has been a member of the PDA for many years and served on the committee since 2004.

Maria Mylonas , Secretary 
Maria is the Head of Learning and Development at PharmOut. Maria has over 20 years’ experience in Quality Control, Quality Assurance, and Learning & Development management roles in the Pharmaceutical, Medical device, and Automotive industries in the Asia Pacific Region. She is a qualified Biological Scientist and educator and routinely trains sector in a wide range of GMP topics including current PIC/S updates, Data Integrity, Quality Risk Management, CAPA, ISO 13485 to name a few. Maria is passionate about program design and competency assessments that align with business strategy and quality culture..

Mark Dickson, Committee Member 
Mark Dickson is a Director, Quality Assurance Compliance, at CSL Behring Broadmeadows. Mark was previously a Senior Global Quality Manager at Novartis International AG managing significant quality incidents and escalations for Novartis Technical Operations and performing GxP audits on behalf of the Pharma QA Compliance & Auditing Group. He also provides expert GMP advice to Pharma QA, assisted in GMP training, supported global commitments and continuous improvement initiatives. Mark previously worked for the Therapeutic Goods Administration (TGA), Office of Manufacturing Quality (OMQ) for 8 1/2 years. Prior to the TGA, Mark worked for 13 years in both quality and manufacturing roles within the pharmaceutical industry.

Usha Gulapalli, Committee Member 
Usha has more than 25 years of experience in Pharmaceutical Industry and with a proven track record of building and leading teams/organizations that deliver results. Over the course of her career, she has demonstrated flexibility and the ability to quickly learn new skills in successfully switching between R&D, Quality and Operations. Usha believes that everyone in an organization has the ability to “Make a Difference” through a culture of accountability and open communication. She has been successful in driving this type of culture and her group has been recognized as the highest performing team in the organization.

Mylinh La, Committee Member 
Mylinh is a biomedical scientist with over 20 years of experience working in both the academic environment as well as the biotech industry. Mylinh gained her Ph.D at the University of Melbourne (Department of Pharmacology). Mylinh left for the industry and joined Murex Biotech Ltd where she spent several years with the Monoclonal antibody Team. She later moved to the Supply Chain management team within the company, overseeing production planning. In 2009, Mylinh returned to Australia and joined the Department of Pharmacology at Monash University as a Senior Research Fellow before moving to CSIRO in 2010. Mylinh is currently the laboratory and production manager of the mammalian CSIRO Tissue Culture facility (CTCF). 

Justine Mann, Committee Member
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.

Maria Mylonas, Committee Member
Maria has over 20 years’ experience in Quality Control, Quality Assurance, and Learning & Development management roles in the Pharmaceutical, Medical device, and Automotive industries in the Asia Pacific Region. She is a qualified Biological Scientist and educator and routinely trains sector in a wide range of GMP topics including current PIC/S updates, Data Integrity, Quality Risk Management, CAPA, ISO 13485 to name a few. Maria is passionate about program design and competency assessments that align with business strategy and quality culture.

Micheal Schafferius, Committee Member
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, Committee Member
Jo is a Senior GMP Consultant at SeerPharma Pty Ltd.
Jo 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 and GMP Training and conducts Quality Assurance Audits.
 

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 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 [email protected].

 

Presentations

This page contains presentations from past meetings.

Note: TGA presentations given at our events are available on the TGA website.