USP <665> and other E&L standards: Single use risk assessment and implementation strategies
Date
12 May 2026
Time
11:00-12:30 ET | 15:00-16:30 GMT | 16:00-17:30 CET
Key features
With USP <665> becoming official in May 2026, biopharma companies are asking the same questions:
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What data are really expected for single use components?
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How does USP <665> align with long standing BioPhorum extractables best practices?
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Where is flexibility still appropriate—and where are regulators drawing firmer lines?
Join us to explore how effective risk assessment, high‑quality supplier data, and alignment with BioPhorum best practices enable companies to meet USP <665> expectations without unnecessary repeat testing—while still maintaining rigorous control over extractables and leachables (E&L) risk.
Building on insights from BioPhorum Drug Substance’s latest publication, this webinar will equip you with the knowledge to strengthen regulatory preparedness, enhance internal decision-making, and foster more productive collaboration between end users, suppliers, and regulators as the industry moves into the USP <665> era.
Webinar registration
Our featured speakers
James Hathcock
Senior Director, Regulation and Validation Strategy
Cytiva
Armin Hauk
Lead Scientist
Sartorius
Jessica Shea
EMPROVE® Program Manager
Merck KGaA Group
Muneeba Khalid
Senior Process Scientist products
Regeneron
Samuel Kikandi
Deputy Director - SME SUS E&L
Sanofi