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Integrity Assurance Strategy for Single-Use Assemblies

WEBINAR

Single-use technology is a fairly new industry compared to others, with respects to specific regulations and compendial standards. This webinar will provide different strategies available to facilitate integrity assurance of the single-use assembly. In the absence of a defined regulatory framework, we will discuss a three pillar integrity assurance strategy that includes quality by design, quality risk management as well as operator training.

In this webinar, you will learn:

Quality by design approach of thoroughly assessing components before they are ever used to ensure the integrity of the single use assembly.
Quality risk management with respects to qualification of junctions, in-process testing, and a variety of application relevant release tests.
Best practices for handling single use assemblies and operator training.

Speaker

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).