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EU GMP Annex 1 Draft — Closed System Design Consideration with Single-Use Systems



WEBINAR

The European Commission published a draft revision of the European Good Manufacturing Practice (GMP), Annex 1, on Manufacturing of Sterile Medicinal Products which will include specific guidance on the use and risk control of single-use systems. Here, it is emphasized that the use of closed systems such as single-use systems can reduce the risk of cross-contamination.

During this webinar, we will focus on points to consider assuring sterility and integrity of a single-use assembly, and how collaboration between supplier and end-user can support the overall contamination control strategy of final filtration and filling operation.

In this webinar, you will learn:

  • What are the EU GMP Annex 1 draft expectations on the use and control of single-use systems
  • Which measures to take assuring the integrity of a single-use system
  • How collaboration between supplier and end-user can support a risk-based contamination control strategy

Speakers

Simone Biel, Ph.D.

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.

Somasundaram G (Som)

Somasundaram G (Som)

Merck

Senior Consultant

Som is a consultant with customers for regulatory compliance, closed processing, and other areas in biopharmaceutical applications. He is also a member of PDA and ISPE industry associations. Som has worked in different functions within Merck for the last 19 years, including heading technology management, tech service, BioReliance® filter validation lab, commercial role, and business development areas. He also worked for a year in QA/QC as well as obtained one year of academic experience in microbiology.