De-Risk USP <665> Compliance for Single-Use Systems, Upcoming Webinar Hosted by Xtalks

In this free webinar, gain insight into how USP <665> risk assessment and screening method qualification can support compliant evaluation of single-use manufacturing components. The featured speaker will share how to approach USP <665> risk assessment, understand screening method qualification expectations and interpret testing requirements in the context of single-use equipment used in pharmaceutical manufacturing.

TORONTO, June 2, 2026 /PRNewswire/ -- As USP <665> becomes official, pharmaceutical manufacturers using single-use systems face new requirements for evaluating extractables and leachables risk, component suitability and analytical testing approaches. This webinar will cover how USP <665> changes expectations for single-use manufacturing components and why reliance on USP Class VI designation, vendor compliance statements and BPOG protocol testing may no longer be sufficient to support regulatory compliance.

The featured speaker will discuss the role of formal risk assessment under USP <665>, including the information needed to assess each manufacturing component and determine where additional screening may be required. They will also examine analytical test methods used to screen single-use components, including how generic methods can be qualified as fit-for-purpose to produce reliable results.

Attendees will learn how to approach USP <665> risk assessment, understand screening method qualification expectations and interpret testing requirements in the context of single-use equipment used in pharmaceutical manufacturing.

Register for this webinar to learn how USP <665> risk assessment and screening method qualification can support compliant evaluation of single-use manufacturing components.

Join James Scull, PhD, Chief Scientific Officer of Extractables & Leachables and Chemistry, BA Sciences, for the live webinar on Tuesday, June 23, 2026, at 1pm EDT (10am PDT).

For more information, or to register for this event, visit De-Risk USP <665> Compliance for Single-Use Systems.

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