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Parenteral Drug Association Connecting People, Science and Regulation ®

About the Australia Chapter

The PDA Australian Chapter Committee Comprises:

David Spaulding, President david.spaulding@seerpharma.com.au
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.

Eoin Hanley, President-Elect eoin.hanley@cslbehring.com.au
Eoin is currently a Quality Assurance Projects 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.

Paul Kerr, Treasurer paul.kerr@seerpharma.com.au  
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.

Lisa Bennett, Secretary Lisa.Bennett@seqirus.com
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.

Kim Waters, Immediate Past President kim.n.waters@gsk.com 
Kim has been in the Pharmaceutical Industry for over 15 years with experience in Manufacturing, Product Development, Capacity Development, Quality and Logistics. Kim is currently responsible for artwork and manufacturing data control at GSK and has been a PDA member since 2008.

Mark Dickson, Committee Member mark.dickson@novartis.com
Mark Dickson is a Senior Compliance Professional at Novartis International AG performing GxP audits on behalf of the Pharma QA Compliance & Auditing Group. He also provides expert GMP advice to Pharma QA, assists in GMP training, support 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.

Paul Doughty, Committee Member pauledward@bigpond.com 
Graduating in 1982 with a degree in Medicinal and Pharmaceutical Chemistry (J. Hons.) Paul has spent his professional career working in the Pharmaceutical and Biotechnology industries and has wide ranging experience with local and international companies and in various consultancy roles. He has been a PDA member since 2006.

Dina El-Emary, Committee Member dina.el-emary@cslbehring.com.au
Dina has over 12 years of experience working in the medical devices and pharmaceutical manufacturing industries.  Currently she is the Quality Compliance & Improvements Manager at CSL Behring.  She is a qualified Mechatronics Engineer and has had varied roles in Engineering, Manufacturing and Quality Assurance, bringing in every role improvements in quality, efficiencies and business process effectiveness.  More recently she has been the lead in significant site-wide compliance improvements at CSL Behring.

Usha Gulapalli, Committee Member usha.gullapalli@hospira.com
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.

John Montalto, Committee Member John.montalto@cslbehring.com.au
John has been working in the life sciences industries for more than 15 years in a range of manufacturing and more recently strategic quality and compliance roles. John has trained and consulted to international regulatory agencies and bodies across the world including the United Nations. At present he is CSL Behring’s Manager, Risk Management, Quality Processes and Training.

Trevor Schoerie, Committee Member trevor.schoerie@pharmout.net
Trevor, Director and Executive Consultant, is PharmOut's founder and driving force. With Senior, General and Executive Management experience in the pharmaceutical, food and chemical industries in various quality, manufacturing, validation, engineering and consulting roles, Trevor understands the business pressures that can arise from regulatory requirements. His vision is to provide industry with practical, cost-effective solutions to regulatory challenges.

Tracy Tay, Committee Member tracy_tay@pall.com
Tracy holds a PhD in Pharmaceutics, postgraduate business qualification in Commercialization and an Honours Degree of Bachelor of Formulation Science (First Class) from Monash University, Australia. She has close to a decade of extensive experience across various roles in R&D, academic teaching and sales within the biopharmaceutical, biotechnology and banking industries. Tracy is currently the Territory Sales and Marketing Manager and Bioprocess Specialist at Pall Corporation for the Biopharmaceuticals Division.

Ano Xidias, Committee Member Anastasios.Xidias@cslbehring.com.au
Ano has worked within the pharmaceutical industry for over 25 years. His management roles have been varied from Quality Assurance, Quality control, Compliance, Product release, Validation, and Manufacturing specialising in sterile manufacture. Ano is currently Manufacturing Manager at CSL Behring. He has been on the committee for number of years, past President of the Australian Chapter and PDA member since 1996.