Navigating EU GMP Annex 1: Effective Strategies for Single-Use Challenges in Bioprocessing
WEBINAR
This webinar will provide recommendations for addressing risks associated with single-use systems raised in EU GMP Annex 1. We will outline a quality approach to ensure performance, robustness, and sterility of single-use assemblies. The session will summarize key points from EU GMP Annex 1 including design, supplier verification, and risk mitigation. Participants will gain insights into how comprehensive supplier testing information can facilitate the effective implementation of single-use systems in drug manufacturing.
In this webinar, you will learn:
- Recommendations for addressing key challenges in single-use systems addressed in EU GMP Annex 1.
- How comprehensive supplier testing information can expedite the implementation of single-use systems.
- Supplier validation topics, including component qualification, sterilization validation, and release testing.
Speakers
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.
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).
Pharma and biopharma manufacturing
- Pharma and biopharma manufacturing
Duration:1h
Language:English
Session 1:presented May 22, 2025
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