Single-use technology (SUT) is well established in all stages of bioprocess manufacturing, including upstream, downstream, and fill/finish unit operations. The implementation of SUT usually starts with development of the user requirement specification (URS). The end users at biopharmaceutical companies work closely with the supplier to select components and assemblies (standard or custom) to meet the application requirements. Single-use qualification and regulatory considerations can include properties such as physical, functional, biological, chemical and sterilization.
This webinar will discuss best practices for single use qualification including quality and regulatory documentation.
In this webinar, you will learn about:
- Implementation of single-use technologies
- Single-use user requirement specifications (URS)
- Best practices for single-use qualification including quality and regulatory documentation
Speakers
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).
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.
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h 9min
Language:English
Session 1:presented February 15, 2024
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