De-Risk USP <665> Compliance for Single-Use Systems

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.

Speaker

James Scull, PhD, Chief Scientific Officer of Extractables & Leachables and Chemistry, BA Science

James Scull, PhD, is the Chief Scientific Officer of Extractables and Leachables (E&L) and Chemistry at BA Sciences. He brings more than 30 years of scientific and industry experience, with expertise in E&L, analytical chemistry, clinical manufacturing, toxicology and multi-dimensional separation science.

Prior to joining BA Sciences, Jim served as Founder, President and Principal Consultant at Pharmxtrax Consulting LLC, and previously held the role of Scientific Director, Life Sciences at Element Life Sciences, where he led complex E&L strategies for pharmaceutical and medical device clients.

Jim earned his BS in Chemistry from Widener University of Pennsylvania and his PhD in Analytical Chemistry from Villanova University. He is a recognized thought leader in the E&L space, with a comprehensive record of publications and industry presentations.

Jim Scull’s leadership and scientific expertise further enhance BA Sciences’ commitment to delivering premier analytical chemistry and E&L solutions for our partners and the life science industry.

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