The ISPE Australasian Affiliate is a legal entity chartered by the parent ISPE organisation in the USA. We are a registered not-for-profit company in Australia.
The Board consists of volunteer directors, all of whom are professionals in the industry. As a minimum, the Board meets every month and holds an annual general meeting, usually in December. Subcommittees are formed at the annual face to face meeting to focus on Stakeholder Engagement, Events, Communications and Corporate Governance.
Kerry Dranganoudis, ISPE Australasia Affiliate President
Kerry has 35+ years experience in the Pharmaceutical industry in Australia, England and the United States and is the Director and principal consultant of Compliance Connection, an Australian based consultancy.
Kerry has experience in the Pharmaceutical (Complimentary, OTC, Rx and Medical Devices) and Veterinary medicines industry including Contract Laboratories in areas of QC, R&D, QA, Packaging, supply and Distribution, with Industry management experience in Australia, England and the United States.
Particular expertise in Warehousing and Distribution, Licensing (State / Territory, ODC), Medicinal Cannabis, Supply Chain complexities, Auditing, Root Cause Analysis (RCA), Risk, Statistics, Quality Systems and Commercial QA.
Implementation of quality Systems (ISO9001, ISO13485, GMP, GWP) and business systems (TrackWise, ERP), improvement of processes through OEE, SPC and Six Sigma methodologies, project managed transfers, product launches, system implementations, compliance gaps, licensing (TGA, State / Territory, ODC) and been a key contributor in the inception of a global pharmaceutical affiliate office and other start-ups.
Kerry is a mentor and coach in compliance, a respected trainer and presenter in multiple facets of GxP, including industry seminars (ISPE, ARCS, pHarmpro, CAPSIG) and lectured at the University of Technology (UTS) Ultimo campus, as part of the Masters of Good Manufacturing Practice (GMP) course (2014 to 2017).
Abdul Fneiche, Vice President
Abdul is a broadly experienced leader in the high-risk pharmaceutical manufacturing space. With a background in compliance, quality, operational management and change management, he currently serves as Process Performance Lead at ANSTO.
Throughout his career, Abdul has spearheaded key initiatives, including capacity expansions, new production lines and facility establishment.
Abdul has a passion for advancing pharmaceutical knowledge and driving the adoption of innovative technologies and has a special interest in high-complexity and high-risk manufacturing operations.
Cameron Roberts, Treasurer
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Matthew Bugg, Secretary
An accomplished Quality Professional and Certified Quality Auditor with over 18 years of experience in the pharmaceutical industry. Experienced in sterile and non-sterile manufacturing, animal healthcare, veterinary products, OTC and Rx medicines, and contract laboratories in areas of QC, QA and packaging. Seasoned in all relevant regulatory guidelines including, but not limited to, PIC/s, TGA, MHRA, CFDA, ICH, ISO, PDA and WHO. Expertise in aseptic, BFS and H2020 Isolator technology, sterile manufacturing with terminally sterilized products, non-sterile manufacturing with tablets, capsules and suspensions, contamination control, quality management systems, quality risk management, warehousing and distribution, GxP auditing and preparing for regulatory inspections. Well-versed in managing QMS systems including annual product quality review, OOS management, data integrity, CAPA, change control, validation, and quality risk management.
Matthew also holds a Masters degree in Pharmaceutical Technology and Quality Assurance, from Leeds University UK and a Pharmacy degree from Birkbeck University London
Stephen Firmer (Past President)
Stephen has over 25 years of experience in the pharmaceutical industry and is currently a Director of Asia Pacific Consultants Pty Ltd, an Australian based consulting group established in 1996 focusing on design and project management, operational and quality management support in the human and animal life science industries.
During his time with Asia Pacific Consultants he has assisted many organisations with quality system improvements, process design, facility design, commissioning and validation as well as with their training and GMP auditing requirements.
Prior to joining Asia Pacific Consultants, Stephen has held senior roles within industry including Multigate (Quality and Regulatory Affairs) and Roche (over 18 years including Technical Management, Production, Logistics and IT implementation projects) as well as within Government at the Australian TGA (Lead Auditor). During his career his work has taken him to many countries in the Asia Pacific region including projects in China, India, Bangladesh, Thailand, Malaysia, Philippines, Taiwan and Indonesia.
Stephen holds a PhD in Pharmaceutics, as well as a bachelor degree in Pharmacy (Hons) from the University of Sydney. As well as being a long term member of ISPE, he is also a member of the Association of Regulatory and Clinical Scientists (ARCS Australia).
Benjamin Sauer, Director
Ben has over 15 years’ experience in the Pharma industry, predominately in technical services and operations management within TGA or FDA approved sterile fill and finish facilities. He is the current Site Technical & Portfolio Lead for AstraZeneca in North Ryde as part of the MLT.
Ben was previously the National Operations and Compliance Director for Global Medical Solutions (GMS) and Radpharm Scientific (2012-18) as part of the Senior Management team. GMS is a Manufacturer of aseptically produced radiopharmaceutical (SPECT and PET) unit doses, with facilities in Sydney, Brisbane and Perth. Radpharm is a Manufacturer of sterile fill and finish LVP, with the sole facility in Canberra. Here his remit included oversight of production processes and facilities, QA and Regulatory Affairs, logistics, & engineering - including their respective P&L.
Prior to GMS/Radpharm, Ben held the positions of Manufacturing Manager for Parnell Life Sciences (2010-12) and Project and Validation Manager for Jurox Pty Ltd (2006-10). His expertise include facility and clean room design and operation, HVAC (clean room and containment), sterilisation process (moist/dry heat), process improvement, lean six sigma and operational excellence. Previous experience include Bioanalytical Chemistry and Research and development (e.g., method development/validation and product development).
Ben holds a PhD in Bio-medicinal Chemistry, as well as bachelor’s degrees in Science (Hons) and Environmental Science.
Maurice Parlane, Director
Maurice Parlane is Principal/Director of New Wayz Consulting Limited, a New Zealand based consulting group focussed on improving quality, operational and business performance for clients in the human and animal life science sectors. He has been in consulting practice for 18 years during which time he has assisted numerous organisations to establish, improve or scale-up manufacturing or supply chain operations in Australasia and the Asia Pacific region.
Prior to establishing New Wayz, Maurice held senior engineering and manufacturing roles within the Glaxo group of companies in New Zealand. He is a professional engineer, holding a Bachelor of Manufacturing Technology (Hons) as well as mechanical and electrical engineering qualifications. Maurice is the immediate Past President of the ISPE Australasia Affiliate, Past Chair of the Asia Pacific Affiliate Council and is active on a number of regional and international ISPE committees.
He holds professional membership of IPENZ, the Institute of Professional Engineers of NZ, and a the NZ Institute of Food Science and Technology. Maurice is the current chairman of the NZ Therapeutic Products Manufacturers Association and a member of PDA and NZBio.
Alicia Steel, Director
Alicia is currently the Regulatory Affairs and Quality Manager/ Quality Nominee for Cryosite, a company that provides Clinical Trial supply chain logistics/distribution services for Australia and New Zealand & manufacturing of Cord Blood Cellular Therapies.
Alicia holds a PhD in Reproductive Biology with a background of biostatistics and management of Quality Management Systems, and her interests include using automation and new technologies to simplify and standardise processes to ultimately increase product / service quality and reduce wastage.