Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382

This webinar focuses on developing a robust and adaptable Contamination Control Strategy (CCS), aligning with the revised EU GMP Annex 1 and preparing for USP <382>.

• Holistic CCS for Annex 1 Compliance: Learn how pharmaceutical manufacturers and suppliers can collaborate to identify, mitigate, and control contamination risks across the supply chain, meeting the holistic requirements of Annex 1. We explore building a "living" CCS through a strong quality culture and knowledge sharing.
• Navigating USP <382>: Understand the new qualification standards for elastomeric components in injectable drug packaging, effective December 1, 2025. This includes stricter requirements for functionality, physicochemical properties, and biocompatibility, as well as considerations for extractables/leachables testing, material compatibility, and risk assessment.
• Integrating Compliance for a Future-Ready CCS: Discover how combining Annex 1 and USP <382> strategies can strengthen risk mitigation and ensure regulatory alignment.

Key Takeaways:

• Building an effective CCS.
• Aligning suppliers with regulatory expectations.
• Understanding and implementing USP <382>.
• Fostering a quality culture and a "living" CCS.