Speakers ⇽ PDA Aseptic Manufacturing Excellence Conference 2024

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Anthony Georgiadis

Sales Director of Amscorp Scientific

Anthony Georgiadis, the Sales Director of Amscorp Scientific, joined the team in 2019, initially serving as an Application Specialist. With a belief in leveraging technology for positive change, Anthony is committed to ensuring that the right people worldwide have access to the right technology to drive impactful improvements. Known for his inclination to challenge conventional wisdom, Anthony brings a dynamic energy to continuously push boundaries, and to foster progress within the scientific community and beyond.

Lisa Bennett

Director of LB Consulting Australia

Lisa Bennett is a seasoned professional in the pharmaceutical and medical device industry, with a diverse background spanning from R&D to aseptic processing and sterile medicine manufacture to Quality Management Systems and auditing.

Being passionate about collaboration and knowledge sharing across industry, she volunteers with the Parenteral Drug Association (PDA) and is an active member of the PDA Board of Directors, PDA Regulatory Affairs and Quality Advisory Board (RAQAB) and the PDA Australia Chapter Board. Through these roles she contributes to the PDA mission of advancing pharma manufacturing science and regulation so members can better serve patients.

Known for her commitment to quality and attention to detail, Lisa actively engages with industry stakeholders, collaborates on knowledge sharing opportunities such as conferences, workshops, training and publications, and stays abreast of medicine regulators’ expectations.

Beyond her work with PDA, Lisa has held roles in industry supporting the manufacture of biologicals and cell and gene therapies, and her consultancy and training services include various aspects of human and animal pharmaceutical manufacturing, including quality assurance, aseptic processing and good manufacturing practices.

Sadman Bhuiyan

Project Manager, Scientist and Educator at Inoviq Limited

Sadman Bhuiyan is a highly accomplished scientist and project manager with over five years of experience in the biomedical and health sciences field. He holds a Master’s degree in Biomedical and Health Sciences from Monash University, where he graduated with High Distinction and received recognitions such as the MNHS Graduate and Monash Talent awards. He also earned a Bachelor’s in Biomedical Science from The University of Sheffield.
Sadman has successfully led numerous high-budget projects, including pharmaceutical manufacturing site setups, R&D site relocations, and laboratory outfitting. Currently, Sadman is a Lead Process Development and Manufacturing Scientist at Inoviq Limited, where he has developed a novel exosome isolation technique and established GMP-compliant manufacturing protocols. His role involves overseeing multiple components of the company’s product pipeline and collaborating on research projects with prestigious universities. His academic contributions include independent research in renal and cardiovascular anti-fibrotic medication at Monash University, where his work has been pivotal in developing a novel diagnostic imaging platform, earning him first-author publications and establishing protocols now considered gold standards. Sadman is actively involved in professional organizations, serving as the President-elect for the S&ECP Division of the Parenteral Drug Association’s Australia Chapter. His diverse background also includes roles in business development, property management, and public health education.

William Dyer

Operational Excellence Associate, Operational Excellence at Pfizer

William Dyer is a Continuous Improvement Associate at Pfizer Melbourne. He holds a Bachelor of Science (Applied Chemistry)/Bachelor of Engineering (Chemical Engineering) (Honours) from RMIT. William has experience in drug substance and drug product manufacturing and excels in technological and innovative solutions for streamlining process streams while maintaining the essential pillars of quality and safety. He has introduced new digital tools to generate, refine, and visualize process simulations in a wide range of activities, providing a deep understanding of the effects and benefits of continuous improvement projects.

Michael Edey

Senior Principal Engineer at Pfizer

Facilitated Discussion on the Challenges in Achieving Aseptic Manufacturing Excellence

Michael Edey is a Senior Principal Engineer at Pfizer Inc., where he holds a role in the Sterile Injectables Technology team, focusing on process reliability and innovation. With over 25 years of experience in the pharmaceutical industry, Michael's expertise spans Production Management, Quality Assurance, and Technical Leadership. His recent work involves global technical leadership in process innovation and simplification, including being the process owner for container closure integrity (CCI) initiatives with a strong emphasis on quality risk management.

Michael is an active contributor to industry standards, including ICH Q9, and has co-authored significant publications such as the BioPhorum Holistic Approach to CCI paper and various PDA publications. He holds a degree in Chemistry and a postgraduate diploma in Manufacturing Management.

Riley Fitzpatrick

Senior Microbiologist BSc at CBE Pure Solutions

Riley has over 20 years experience in the Pharmaceutical Industry and is highly skilled in all facets of Microbiology. Riley brings an array of experience including the development of method validation protocols and reports, along with reviewing proposed updates to pharmacopoeia to ensure ongoing compliance with specifications. In previously held positions Riley has led and trained staff while ensuring testing and reporting priorities are met. Riley also has extensive knowledge of laboratory investigations through to completion

Robyn Hofer

Operations Manager at CBE Pure Solutions

Robyn has 20 years extensive pharmaceutical experience within the QC Laboratory. Robyn has a proven ability to ensure compendial and regulatory compliance and establish quality systems. Robyn has experience in co-hosting and participating in TGA, FDA and ANVISA regulatory inspections, customer audits and is yellow belt certified. Robyn is also qualified as a NATA technical assessor. Additionally, Robyn is a skilled change agent in challenging, influencing and supporting departmental practices, policies, systems, attitudes, and structures.

Andy Hopkins

Senior Director of Lachman Consultants

Andrew has a BSC (Hons) in Microbiology with Genetics and a Post Graduate Diploma in Industrial Pharmaceutical Science. His career history covers a number of areas over approximately 35 years.

Currently, Andrew is a Senior Director at Lachman Consultants. Prior to this, he served as the Director of Compliance at Abbvie and his role included Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

Andrew was an Inspector with the MHRA for nearly 14 years before joining the private sector.

Daniel Klein

Senior Manager, Technical Services at STERIS

Dan has over 28 years of industry experience, including over 20 years managing research and development and contract testing laboratories for microbiology and clinical affairs. Dan holds a master’s degree in biology and a bachelor’s degree in microbiology
At STERIS Life Sciences, Dan provides technical expertise to Customers and helps troubleshoot and solve contamination issues. He supports Customers with a variety of critical processes and general understanding of the latest developments in the industry. He frequently presents data and other information at international industry meetings and sponsored events.
Throughout his professional experience, Dan holds several patents and has authored numerous industry articles and book chapters in peer-reviewed journals related to disinfection and sterilization.

Andrea Kurz

Senior Director, External Advocacy Europe and Middle East of F. Hoffmann-La Roche Ltd

Andrea Kurz is Senior Director, External Advocacy Europe and Middle East at F. Hoffmann-La Roche Ltd in Basel, Switzerland. Andrea has 20+ years’ experience in the Pharmaceutical Industry and held various positions in Quality & Compliance and Regulatory Affairs. She is a pharmacist by education and graduated from the Ruprecht - Karls - Universität Heidelberg in Germany.

With focus on Europe and the Middle East she leads External Collaboration Policy and Strategy activities in Quality and Compliance. She actively leads or participates in committees in trade and individual member associations related to strategic quality initiatives, regulations, and conferences. She acts as an advisor for management and staff in the areas of Quality and Compliance and provides policy information regarding external regulations and trends.

As a qualified GMP Lead Auditor she gained excellent knowledge of cGMP regulations and Pharma Quality Systems. As an experienced People Manager and Matrix Leader she has built and led global and cross-functional teams and has established knowledge networks and stakeholder collaborations.

Mylinh La

Senior Lab Manager at CSIRO

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.

Brent Lieffers

Senior Director of Innovation Advocacy at Cytiva

Brent is currently the Sr. Director of Innovation Advocacy, having joined Cytiva in 2022 as the general manager for the company’s Aseptic Filling business. He has over 30 years of extensive experience in the pharmaceutical industry, from API manufacture through to fill/finish, in operations ranging from small clinical to large commercial scale production. Driving innovation in drug product manufacturing, Brent is an advocate for outcome-based regulatory compliance based on QBD, robust risk assessment, data and scientific rationale with the ultimate goal to improve patient safety.

Malcom Hammond

Director, Manufacturing Quality and Licensing & Assurance (AERP | Recalls | HGP) of Australian Pesticides and Veterinary Medicines Authority

Malcolm is the Director, Manufacturing Quality & Licensing and Assurance (AERP | Recalls | HGP) at Australian Pesticides and Veterinary Medicines Authority and has been with the agency since November 2022.

Malcom has previously worked at TGA as Senior Assessor for the evaluation of GMP clearances for overseas manufacturers for 5½ years and earlier held other regulatory positions within the Department of Health. Malcom has also previously held significant technical positions in innovative and generic pharmaceutical companies, both in Australia and the UK supplying non-prescription, prescription and speciality hospital products to various world markets.

Justine Mann

Chief Executive Officer at CBE Pure Solutions

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, a leading consulting firm providing service to the 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.

Tanvi Maturi

CSL Behring

Tanvi Maturi is an individual who is passionate about visualising data to provide meaningful insights. After working at various scientific organisations and realising the need for more automated reporting tools, she endeavoured to learn and implement data-governance strategies and make use of data-visualising technologies. Currently working at CSL Behring as a Senior Quality and Compliance Associate, Tanvi is responsible for gathering and visualising quality data for the site, helping leaders throughout the business understand their KPIs and enabling them to make impactful decisions.

She has a Bachelor of Science from the University of Melbourne, majoring in Neuroscience and a Masters in Biotechnology from RMIT, majoring in Clinical Microbiology.

Fergus O'Connell

Head of Quality - AU/NZ at Eurofins ams Laboratories

Peter Qiu

External Advocacy Lead, APAC at Roche Genentech

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.

Micheal Schafferius

Application Specialist for Separation Technologies and Quality at SARTORIUS

Micheal Schafferius is currently the Application Specialist for Separation Technologies at Sartorius Australia and serves as the APAC Filter Integrity Champion. He has been with Sartorius for 12 years and brings over 20 years of experience in the pharmaceutical and biopharmaceutical sectors. Micheal’s expertise encompasses Filtration, Single-Use Technologies, Quality Assurance, Validation, and Sterile Manufacturing, gained through roles with both local and international companies. He is a recognized subject matter expert in Pre-Use Post-Sterilization Integrity Testing of filters and frequently presents on this topic at regional conferences.
Micheal also recently concluded his term as President of the Parenteral Drug Association (PDA) Australia chapter and continues to contribute as an active core committee member.

Nadia Seidel

Site Operational Excellence Lead at Pfizer

Jo Sherriff

Engineering Compliance Manager at SeerPharma Pty Ltd

Jo Sherriff is the Engineering Compliance Manager at SeerPharma, a consulting firm providing best-practice advice and training to pharmaceutical, medical device and life science companies in the Asia-Pacific region on matters of Quality and GMP compliance.

Jo has over 25 years’ experience in the pharmaceutical and life science industry. Jo is a qualified Chemical Engineer with her career spanning roles in process design, site operations, qualification/validation, GMP facility design and development of quality document systems. Jo’s extensive consulting and hands-on experience enables her to provide project management and practical GMP compliance advice from the facility concept design phase through to completion of process validation activities, in readiness for regulatory inspection.

Jo is Treasurer of the PDA Australia Chapter.

Kim Sobien

Senior Microbiology Consultant at ValSource

Kim Sobien is a Microbiology Senior Consultant with ValSource, Inc. Her pharmaceutical industry career encompasses a breadth of Quality, Compliance, and technical experience with injectable pharmaceutical products, including parenteral pharmaceutical contract manufacturing, pre-filled syringe generics, radiopharmaceuticals, and biologics. Previously she has served as MSAT Contamination Control Lead and a GSK Fellow at GSK, Principal Sterility Assurance Engineer for PETNET Solutions, Associate Director of Regulatory Compliance at Merck, Regulatory Compliance Lead at BD Rx, Inc., and Microbiology Laboratory Manager at Oso BioPharmaceuticals (now Curia).

Kim has a BS in Microbiology from the University of Wisconsin–La Crosse and a Master of Business (MBA) degree with an emphasis in Global Management from the University of Phoenix. She is an active member of the Parenteral Drug Association (PDA), the PDA Southeast Chapter, and a past co-chair of the PDA Annual Global Conference on Pharmaceutical Microbiology.

Craig Stephens

Senior Director Quality of CSL Behring (Australia) Pty Ltd

Hai Tran

Senior Manufacturing Area Manager – HS&S Filling at CSL Behring

Andrew Treller

Continuous Improvement Specialist, High potent - Production at Pfizer

Andrew Treller is a Continuous Improvement Specialist at Pfizer Melbourne. With over 5 years of experience in sterile injectable plants, he excels in leveraging data for continuous improvement, enhancing production efficiency, quality, and safety. Andrew possesses strong leadership and problem-solving skills in managing facility operations. He has a proven track record in project management, regulatory compliance, and team mentorship. Andrew is dedicated to operational excellence and process optimization through insightful data analysis.

Stelios Tsinontides

Director of CDER's Office of Pharmaceutical Manufacturing Assessment US FDA

Dr. Stelios Tsinontides is Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA) under the Office of Pharmaceutical Quality (OPQ) in CDER. Dr. Tsinontides has over 30 years of experience in the pharmaceutical industry. OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at commercial scale and provides leadership and technical expertise to Agency components internal and external to the Office of Pharmaceutical Quality regarding manufacturing quality issues.
Prior to joining the FDA, Dr. Tsinontides served in senior-level positions in the pharmaceutical industry - most recently as Shire’s Head of Small Molecule Drug Product Technical Services. His group was responsible for providing scientific and technical expertise for SM Drug Product scale-up and commercial manufacturing activities worldwide, to ensure establishment of commercial robust manufacturing processes and a continuous supply of product to patients.
Dr. Tsinontides holds a B.E. in Chemical Engineering from City College of CUNY and an M.A. and Ph.D. in Chemical Engineering from Princeton University. He has also attended the Wharton Management Program at the University of Pennsylvania. Dr. Tsinontides was elected Fellow at the American Institute of Chemical Engineering (AIChE) in 2016.

Andrew Watson

Director of Centre for BioPharmaceutical Excellence (CBE)

Andrew has designed, constructed, qualified and operated cleanrooms over 25 years. As independent chair for Standards Australia ME-060 (Controlled Atmospheres), Andrew is the Australian recognised expert in cleanrooms and provides his expertise writing international standards. Andrew will oversee the project and ensure that the facility is designed, constructed and qualified to the required standards and build a sound strategic future for the business.

Steve Williams

Director of SWA Biopharm P/L

• 50 years (and counting) in industry
• Almost 20 years in industry operations at CSL and now Hospira plant.
• 32 years consulting mainly in high end technology: Sterile, ATMPs and Biologicals
• Expertise in quality systems optimisation and compliance remediation including pre and post regulatory inspections
• Designed, developed and delivered multiple industry training programs in Australia and Regionally
• 27 years as a Veterinary Medicines auditor for APVMA
• Head Office in Melbourne, other offices in Brisbane, Auckland and Hong Kong
• Works regionally including India, China, Japan and Hong Kong

John Wrenn

Country Manager, Australia & New Zealand at CAI Australia Pty Ltd

Product Demo by CAI: CAI Operational Readiness Model

John is a seasoned validation engineer and project manager and is CAI’s country manager for Australia and New Zealand with more than 20 years of professional engineering experience and a background in Mechatronics. John has worked with CAI on various projects for clients such as J&J Vision, Jazz Pharmaceuticals, MSD, CSL Behring, and Moderna. John has also served as an operations and engineering manager for a medical devices service provider, responsible for project management, IQ/ OQ/PQ, validation, and qualification activities for various clients (startups and established industry leaders). He has experience addressing audit requests for clients from various regulatory agencies and ensuring continued compliance with regulations. He has further knowledge in sterile packaging design and development for large-scale clients and novel start-ups

Speakers

Anthony Georgiadis

Lisa Bennett

Sadman Bhuiyan

William Dyer

Michael Edey

Riley Fitzpatrick

Robyn Hofer

Andy Hopkins

Daniel Klein

Andrea Kurz

Mylinh La

Brent Lieffers

Malcom Hammond

Justine Mann

Tanvi Maturi

Fergus O'Connell

Peter Qiu

Micheal Schafferius

Nadia Seidel

Jo Sherriff

Kim Sobien

Craig Stephens

Hai Tran

Andrew Treller

Stelios Tsinontides

Andrew Watson

Steve Williams

John Wrenn

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