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Upcoming Webinar on USP <665> Compliance

As pharmaceutical companies transition to single-use systems, the official implementation of USP <665> introduces significant changes and requirements. For manufacturers, this means a more rigorous evaluation process regarding extractables and leachables, component suitability, and analytical testing approaches.

In a free upcoming webinar, participants will gain vital insights into how to navigate the complexities of USP <665>. Hosted by Xtalks, this session will feature James Scull, PhD, the Chief Scientific Officer of Extractables, Leachables and Chemistry at BA Sciences. Dr. Scull will explain the essential components of risk assessment needed under the new standard for ensuring compliant evaluations of single-use manufacturing components in the pharmaceutical industry.

The Importance of USP <665>

USP <665> outlines a structured framework for assessing risks tied to components used in pharmaceutical manufacturing. As manufacturers adapt to these new guidelines, relying solely on USP Class VI designation or vendor compliance statements is no longer sufficient. The webinar will explore the critical shift in the approach manufacturers must adopt — one that prioritizes comprehensive risk assessments and thorough testing processes to meet regulatory compliance.

Our featured speaker will delve into the intricacies of risk assessment required by USP <665> and emphasize the importance of obtaining detailed information for every manufacturing component. Participants can expect to learn how to identify areas that may require additional screening processes and how to implement the appropriate analytical testing methodologies.

One important aspect of the discussion will focus on the various analytical test methods applicable for evaluating single-use components. Dr. Scull will share insights on how to qualify generic methods to ensure they are fit for purpose, thereby enabling them to yield reliable and valid results in compliance with USP <665> expectations.

What Attendees Will Learn

During the live webinar, attendees will learn:

• - How to conduct a risk assessment in accordance with USP <665> guidelines.
• - The expectations surrounding screening method qualifications.
• - How to interpret testing requirements concerning single-use pharmaceutical equipment.

This webinar is particularly relevant for professionals involved in pharmaceutical manufacturing, quality assurance, and regulatory compliance. By participating, attendees will be better equipped to navigate the complex landscape of regulatory expectations and ensure that their products meet the high standards required by the industry.

Registration Details

The webinar is scheduled for Tuesday, June 23, 2026, at 1 PM EDT (10 AM PDT). Interested participants can register by visiting the Xtalks website. This is an excellent opportunity to stay informed about the latest developments in compliance and quality assurance in the pharmaceutical sector.

About Xtalks

Xtalks — The Life Science Community™ — serves as a vital resource for professionals across the pharmaceutical, biotech, medtech, healthcare, and research sectors. The platform provides knowledge-sharing, insightful discussions, and collaborative opportunities designed to advance individual and industry-wide success. Annually, thousands of professionals utilize Xtalks for relevant updates and peer insights, ensuring they remain connected and informed.

To learn more about Xtalks or to explore hosting a webinar, visit the official website or contact them directly. Don’t miss this chance to enhance your understanding of USP <665> and its implications for single-use systems in pharmaceutical manufacturing!