Webinar: Single-Use assemblies’ compliance through the lens of the new EMA Annex 1 guidelines

Single-Use Assembly Compliance & New EMA Annex 1 Guidelines

The new Annex 1 provides guidance for the design, validation, and quality control of single-use assemblies. Drug manufacturers need to have a contamination control strategy in place to maintain a consistent and high level of quality, purity, and effectiveness of their drug products.

What Will You Learn:

Better understand the requirements of the Annex 1
How Sartorius is complying with these requirements
Single-Use product performance to meet compliance needs

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Thomas Flouquet

Product Manager 3D Bags

Thomas Flouquet is a Product Manager for Fluid Management Technologies at Sartorius, where he oversees single-use 3D bags. He has almost 20 years of engineering and marketing experience in biopharmaceutical manufacturing and two master’s degrees — one in biotechnology from the Biotechnology Engineering Institute of Bordeaux and one in marketing management from ESSEC business school in Europe.

Nathalie Pathier

Product Manager Applied Services

Nathalie Pathier joined Sartorius in 2019 and has more than 30 years of experience in bioprocessing. She started as a project leader and now works as a Product Manager in Applied Services for Fluid Management Technologies. She focuses on the quality attributes of single-use technologies for critical drug manufacturing applications, and works to develop new services that solve pain points and simplify implementation in biotech modalities processes.