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Webinar: CCI Testing & Revisions to the EU Annex 1

Lighthouse Instruments

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Webinar: CCI Testing & Revisions to the EU Annex 1

85 просмотров · 5 мес. назад
Lighthouse Instruments
69 подписчиков
85 просмотров · 5 мес. назад
The revised EU GMP Annex 1 introduced stricter expectations for container closure integrity testing — moving the industry firmly toward deterministic methods and away from legacy probabilistic approaches. For manufacturers already compliant with USP 1207, the transition is manageable. For those who aren't, the clock is running. In this webinar, Lighthouse Instruments breaks down what the Annex 1 revisions mean for CCI testing in practice — and presents concrete CCIT solutions aligned with the proposed requirements. What's covered: The regulatory environment for CCI: USP 1207, the revised EU Annex 1 draft, and impact on industry best practice's CCIT solutions to meet proposed Annex 1 requirements: Filling line CCI qualification Statistical CCI process study Raised stopper height qualification Q&A Who this is for: QA Managers, Validation Specialists, Regulatory Affairs professionals, and Process Engineers preparing for EU GMP Annex 1 compliance in sterile pharmaceutical manufacturing. 🔗 Learn more: www.lighthouseinstruments.com 📩 Contact us: euinfo@lighthouseinstruments.com #AnnexI #CCIT #ContainerClosureIntegrity #USP1207 #GMP #PharmaceuticalValidation #LighthouseInstruments #FillingLine #StopperHeight #RegulatoryCompliance