Home WebinarsClosed Sampling: Crucial for Aseptic Processing in Manufacturing Quality and Regulatory Compliance

Closed Sampling: Crucial for Aseptic Processing in Manufacturing Quality and Regulatory Compliance

WEBINAR

In today's rapidly evolving industry, a good understanding of closed sampling is essential for achieving compliance and ensuring quality.

In this webinar, we will explore the regulatory framework that guides sampling methodologies and outline the key qualifications necessary for effective sampling assembly, including system integrity evaluations. We will discuss the implications of these practices for aseptic manufacturing and quality assurance. Join us to enhance your knowledge of how closed sampling can strengthen bioprocessing practices and support operational excellence.

In this webinar, you will learn:

Regulatory considerations
Qualification to perform before using a sampling assembly (attributes: verify that it is closed, impact on testing …)
Supplier's manufacturing and quality approach
Good sampling practice

Speakers

Simone Biel, Ph.D.

MilliporeSigma

Senior Regulatory Consultant

Simone Biel provides regulatory and scientific expertise to our customers and internal stakeholders globally with a focus on single-use technology. Over the years, Simone has supported biopharmaceutical drug manufacturers’ implementation of single-use technology in their manufacturing process. With her deep understanding of single-use technology market needs and industry trends, she is the subject matter expert to ensure that product performance meets quality and regulatory requirements. Simone holds a Ph.D. from the University of Frankfurt in microbiology.

Nadine Eberhardt

MilliporeSigma

NovaSeptum^® Strategic Product Manager

With a master in marketing management from Northeastern University, she joined MilliporeSigma in 2008 and held various customer-facing roles in the single-use business. She previously worked in the customer service department and then held different marketing position. She is currently a NovaSeptum^® Sampling Solution Senior Strategic Product Manager.