Save your spot today and gain a roadmap to compliance and inspection readiness.
Join our webinar on Tuesday, October 21, 2025, where our experts from Gateway Analytical will host an essential webinar explaining how to navigate the upcoming regulatory changes impacting sterile packaging. By December 1, 2025, USP <382> will replace <381>, requiring system-level functional suitability testing of elastomeric components in vials, syringes, cartridges, and infusion systems. At the same time, EU GMP Annex 1 mandates validated deterministic container closure integrity testing, confirming that visual inspection alone is no longer sufficient to prove closure integrity.
This session will provide a clear, practical breakdown of USP <382> and its companion chapter <1382>, outlining how the requirements differ from <381> and what categories of functional suitability testing are now in scope. Attendees will gain insight into why elastomer performance must be assessed at the system level and how to justify study design under the new framework.
We will also clarify the sterility assurance expectations of Annex 1 and its connection to USP <1207> deterministic CCIT. The webinar will address common blind spots, from sample size requirements to sponsor-defined acceptance criteria, providing a roadmap for aligning packaging, integrity testing, and compliance strategies in parallel.
Key Learning Objectives include understanding the shift from USP <381> to <382>, leveraging USP <1382> for program design, connecting Annex 1 with USP <1207>, and identifying steps to avoid compliance gaps by December 2025.
Register early to gain clear, actionable insights into how USP <382> and Annex 1 are creating a unified compliance expectation. Companies that align early will be positioned for compliance and sterility assurance, while those that delay risk regulatory gaps at launch.
