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 Expert
Simone specializes in Single-Use Technology and filtration within biopharmaceutical manufacturing. She provides regulatory guidance to diverse stakeholders and has helped many drug manufacturers successfully implement Single-Use Technology. Her main focus is to ensure product performance meets quality and regulatory standards. Simone is an active member of the Parenteral Drug Association (PDA) and BioPhorum. She holds a Ph.D. in Microbiology from the University of Frankfurt.
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.
Pharma and biopharma manufacturing
- Sampling
Durée:1h 1min
Langue:English
Session 1:présenté(e) June 24, 2025