As single-use technology becomes more prevalent in critical applications, there is greater scrutiny from regulators and stakeholders with respects to particulate contamination. Particulate matter can enter the system from various sources, including raw materials, the environment, and the manufacturing process. The presence of particulates can affect the quality and safety of the final drug product, leading to potential adverse patient outcomes. In this webinar, we will share examples of continuous particulate improvements in prevention as well as detection. We will also explore tools such as a particulate library and the use of analytical evaluation thresholds to navigate particulate contamination events.
In this webinar, you will learn:
- Challenges in particulate detection and the regulatory landscape
- Key pillars of particulate risk mitigation for suppliers and end-users
- Examples of continuous particulate improvements in prevention as well as detection
- Tools such as a particulate library and use of analytical evaluation thresholds to navigate particulate contamination events
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
期间:1h
语言:English
场次 1:往期 December 12, 2024
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