Compliance in Conversation

On-Demand Webinar | Compliance in Conversation: A Fill and Finish Regulatory Roundtable

Join Sartorius experts for an interactive panel that sheds light on the key compliance topics shaping fill and finish today. The discussion will provide practical insights on Annex 1 expectations, including strategies for mitigating risk when implementing PUPSIT and preparing your organization for inspection readiness. Panelists will share real-world experiences, lessons learned, and best practices for aligning operations with evolving regulations.

The conversation will also explore PFAS legislation and cover the latest updates, the move toward PFAS-free materials, and what these changes mean for manufacturers. Additional topics will include developing effective contamination control strategies (CCS), understanding inspector expectations, and building strong validation approaches.

Whether you’re focused on risk management, compliance planning, or supplier collaboration, this session offers a clear, practical view of how to stay ahead in an increasingly complex regulatory environment.

What You Will Learn:

Understand evolving compliance expectations and the role of CCS.
Ensure sterility assurance with PUPSIT, single-use systems, and validation.
Stay ahead of regulations, including PFAS policies on the horizon.

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Amine Djeffal

Process Expert

Amine Djeffal specializes in chemistry, manufacturing, and controls for pharmaceuticals and biologics, expertly navigating the regulatory frameworks of the US FDA and Health Canada. As a Process Expert, he focused on phase appropriate product development, post-approval change management, single use systems, and GMP requirements for new facilities.

Yvonne Groß

Senior Scientist

Yvonne Groß has been working for Sartorius since 2007, where she is Senior Scientist for Confidence^® Validation Services. She earned her engineering degree at the University of Applied Science in Köthen, Germany.

As of 2007, she has been working in the field of process specific filter validation. As a subject matter expert in that area, she is working on Sartorius’ global customer specific validation topics and strategies. As an active member of ASTM she is supporting the creation of standards and best practices.

Mathias Siebner

Product Specialist, Separations Technologies, Filtration

Mathias studied chemistry at the University of Braunschweig and received his PhD at the Helmholtz Centre for Infection Research. He has almost 30 years of experience in filtration, covering applications from laboratory to bioprocess filtration. Today, he serves as a Product Specialist for Filtration Technology, focusing on integrity testing and regulatory requirements related to final filtration.

Markus Junior Maring

Product Manager, Filtration Consumables

Markus Junior Maring is Product Manager for Sterile Filtration at Sartorius, where he leads the rollout of Sartopore^® Evo, a new generation of PFAS-free filters designed to meet modern regulatory and sustainability expectations. With a background in microbiology and medical engineering, Markus first joined Sartorius in 2022 in the Confidence^® Validation Services. Supporting biopharma customers through complex validation projects — an experience that shaped his belief that innovation only matters when it works in real processes.

Currently pursuing an MBA at Edinburgh Business School, he focuses on bridging scientific innovation with strategic business value. Markus is passionate about helping provide effective and efficient solutions and thereby simplifying the processes of Sartorius' customers. All the while ensuring compliant, and reliable filtration solutions that help biopharmaceutical manufacturers deliver safer medicines to patients worldwide.

Paolo Saccà

Field Account Project Manager

Dr. Paolo Saccà holds a degree in Pharmaceutical Chemistry and Technology from the University of Pisa. Following a brief tenure as a researcher at the same institution, during which he published in the European Journal of Medicinal Chemistry, he embarked on his professional journey as the Head of Aseptic Filling and Freeze-Drying Departments at Menarini Farmaceutici in Florence, a role he held for five years. He then transitioned to the radiopharmaceutical sector, serving as Production Manager at Nycomed Amersham Sorin in Saluggia, Vercelli, for nine months. Dr. Saccà subsequently entered the biopharmaceutical industry as a Pharmaceutical Production Manager at Kedrion Biopharma in Bolognana, Lucca, where he spent nearly 16 years overseeing aseptic filling, freeze-drying, visual inspection, and secondary packaging departments.

In June 2016, Dr. Saccà joined Sartorius as a Strategic Accounts Project Manager and Final Filling Specialist. In addition to his technical and sales responsibilities, since 2020, he has been contributing to two post-bachelor second-level University Master's Degree programs in "cGMP Compliance & Validation in the Pharmaceutical Industry" at the University of Pavia and the University of Padova.