Speakers ⇽ PDA Aseptic Manufacturing Excellence Conference 2024

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.

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.

Andrew Watson

Director of 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.

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.

Andrew Hopkins

Director of Compliance at AbbVie

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 Director of Compliance at Abbvie the role includes Auditing of manufacturing sites, Training and mentoring, and interaction with regulatory agencies.

Prior to this, Andrew was an Inspector with the MHRA for nearly 14 years.

Lisa Bennett

GMP Senior Consultant & Trainer at SeerPharma

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.

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.

Justine Mann

Chief Executive Officer at CBE Pure Solutions

Session 2 - Veterinary Medicine Regulation and Manufacture

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

Justine is also a 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 elect for the PDA, Australian chapter

Mylinh La

Senior Lab Manager at CSIRO

Session 5 - Establishing Programs Supporting the Contamination Control Strategy

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.

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.

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.

Malcolm 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.

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.

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.

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

Session 4 - Case Studies

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

Session 9 - Case Studies - Using Data Analytics to Achieve Manufacturing Excellence

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.

Steve Williams

Director of SWA Biopharm P/L