The recently published revision to Eudralex Vol. 4 Annex 1, clarified current expectations for the manufacture of sterile medicinal products in light of improved process understanding and advances in processing technologies.
This webinar will summarize important elements of this revision and highlight how single-use filtration systems can contribute to a holistic contamination control strategy helping drug manufacturers meet regulatory expectations.
In this webinar, you will:
Simone Biel, Ph.D.
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.
Senior Program Manager
Monica Cardona is a senior program manager for single-use and integrated systems at MilliporeSigma. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing.
Monica holds a B.S. in Biology from Hofstra University and an M.S in Biology from Adelphi University. She has published and lectured internationally on a wide range of filtration, validation, and single-use bioprocessing topics. Monica is a member of the Parenteral Drug Association (PDA), BioPhorum, and a founding member of Bio-Process Systems Alliance (BPSA).
Product Manager, Final Filtration
Lauren Kacmarcik is a product manager focused on developing solutions that advance sterile filtration. She holds a B.S. in Management and Engineering for Manufacturing from the University of Connecticut.
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