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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:

  • What data are really expected for single use components?

  • How does USP <665> align with long standing BioPhorum extractables best practices?

  • 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

Webinar
Webinar

James Hathcock
Senior Director, Regulation and Validation Strategy
Cytiva

Armin Hauk
Lead Scientist
Sartorius

Webinar
Webinar
Webinar

Jessica Shea
 EMPROVE® Program Manager
Merck KGaA Group 

Muneeba Khalid
  Senior Process Scientist products
Regeneron

Samuel Kikandi
  Deputy Director - SME SUS E&L
Sanofi

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