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.
Merck
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.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented June 24, 2025
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