This webinar will provide recommendations for addressing risks associated with single-use systems raised in EU GMP Annex 1. We will outline a quality approach to ensure performance, robustness, and sterility of single-use assemblies. The session will summarize key points from EU GMP Annex 1 including design, supplier verification, and risk mitigation. Participants will gain insights into how comprehensive supplier testing information can facilitate the effective implementation of single-use systems in drug manufacturing.
In this webinar, you will learn:
- Recommendations for addressing key challenges in single-use systems addressed in EU GMP Annex 1.
- How comprehensive supplier testing information can expedite the implementation of single-use systems.
- Supplier validation topics, including component qualification, sterilization validation, and release testing.
Speakers
Jessica Shea
Merck
Emprove® Program Manager
Jessica Shea is the Emprove® program manager responsible for filters, single-use, and chromatography resin portfolios within Merck. Previously, she was responsible for extractables and leachables global support for the BioReliance® validation services. She has more than 15 years of E&L experience, including method validation, designing of custom testing, and interpreting industry and regulatory guidance. Jessica has a B.S. in biochemistry and an MBA.
Monica Cardona
Merck
Senior Program Manager
Monica Cardona is a senior program manager for single-use and integrated systems at Merck. She has worked in life sciences for more than 20 years. She has had several global roles in technical, strategic, and operational marketing. She currently works cross-functionally with quality, Emprove®, regulatory, operations, R&D, and commercial teams, to create and implement product portfolio enhancement programs that differentiate product offering, improve customer satisfaction and drive portfolio growth. 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).
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented May 22, 2025
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