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
{hcompany}
Emprove® Program Manager
Jessica Shea is the Emprove® program manager responsible for filters, single-use, and chromatography resin portfolios within {hcompany}. 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
{hcompany}
Senior Program Manager
Monica Cardona is a senior program manager for single-use and integrated systems at {hcompany}. 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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