What Do You Need to Do to Qualify a Single-Use Assembly?
WEBINAR
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
Global Senior Program Manager- Single Use & Integrated Platform Solutions
Monica Cardona is senior program manager for single-use and integrated platform solutions at our company, with 20+ years in life sciences across technical, strategic, and operational marketing roles. She leads cross-functional portfolio enhancement programs with quality, Emprove®, regulatory, operations, R&D, and commercial teams. She holds a B.S. from Hofstra and an M.S. from Adelphi, and is an active author, speaker, and industry member (PDA, BioPhorum, BPSA board).
Jessica Shea
Merck
Senior Program Manager, Emprove® Program
Jessica Shea is the Emprove® senior 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