Home WebinarsAssemblies Are Not Particulate Free, Strategies for Risk Mitigation

Assemblies Are Not Particulate Free, Strategies for Risk Mitigation

WEBINAR

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.