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
{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:Thu, March 27, 2025 4:00 PM CEST
To continue reading please sign in or create an account.
Don't Have An Account?