Sartorius Webinar: EU GMP Annex 1: What is important in fill and finish?
Concept
Join Us!
With the updated EU GMP Annex 1 guidelines bringing increased focus on contamination control and risk management, it’s more important than ever to understand what compliance looks like in practice.Join us in this webinar as we explore the critical steps in fill and finish operations and the factors that ensures product sterility, quality, and patient safety.
In this session, our expert speakers will guide you through each step of the fill and finish process—from freeze and thaw, final formulation and final filtration to final filling,—while breaking down the specific Annex 1 requirements associated with each stage. You’ll gain practical insights into what regulators are looking for during audits and where the most observed common gaps and risks lie.
We’ll also share how Sartorius supports these requirements, including recommended approaches, technologies, and best practices to help you strengthen your contamination control strategy, improve operational efficiency, and stay inspection-ready.
Whether you’re in quality, manufacturing, or regulatory roles, join us to deepen your understanding of Annex 1 and walk away with practical information to improve annex 1 compliance.
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Highlights
- Gain valuable insights and explore practical applications through scientific talks.
- Explore cutting-edge solutions at our product demonstrations and exhibition.
- Connect & engage with industry experts and peers to discuss innovative strategies for utilizing Sartorius' solutions.
Sessions
Agenda
Esteemed Voices From the Industry
Our selected experts will share insights on the latest trends, challenges, and developments in this dynamic field. Engage in unique discussions, learn about cutting-edge scientific discoveries, and explore the future of biopharmaceuticals with these influential thought leaders.
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 13 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 concluded his term as President of the Parenteral Drug Association (PDA) Australia chapter in 2024 and continues to contribute as an active core committee member.
Laura holds a master's degree in Biochemistry and Molecular Biology and has over 9 years of experience in biopharmaceutical manufacturing. She worked as a Key Account Specialist at Merck PS, gaining over 4 years of experience in drug manufacturing processes. She then joined Sartorius as an FMT Product Specialist, with expertise in design, operation, troubleshooting, and technical support in the biopharma industry. Laura is also skilled in optimizing biopharmaceutical processes through the strategic integration of single-use technologies.
Dickson holds a Bachelor’s degree in Biological Science from Nanyang Technological University,Singapore (2016). He has published research in Molecular Therapy and Scientific Reports. Aftergraduation, Dickson worked as a Biotechnologist at Shire Singapore and later became a shift teamdeputy. He then joined Takeda Singapore as an Operational Specialist, focusing on businessexcellence and process improvement.
In November 2021, he joined Sartorius as APAC Engineer to Order Project Leader, designingcustom single-use solutions and ensuring GMP compliance. In 2025, he became the Asia FillFinish Product Specialist, supporting stakeholders and leading the business strategy for the fillfinish portfolio in Asia.
Dickson is also Lean Six Sigma Green Belt and PMP certified.
Niveditha Shetty is a Product Specialist for Freeze and Thaw technologies at Sartorius, supporting customers across the APAC region. She brings over ten years of experience in the biopharmaceutical industry, with strong technical expertise in single‑use (SU) systems and downstream processing. Niveditha holds a Master’s degree in Biotechnology from Bangalore University and began her career at Sartorius in product development, building a strong foundation in bioprocess equipment and applications. Her experience spans roles at Pall Corporation as a Senior Sales Engineer and Grindwell Norton (Saint‑Gobain) as Manager – Healthcare. Since rejoining Sartorius in 2019, she has specialized in freeze and thaw applications, working closely with pharmaceutical and biopharmaceutical customers on process design, scale‑up, and best‑practice implementation.