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Webinar: A holistic strategy to ensure Container Closure Integrity of sterile injectable product
Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (CCI) testing. The increasing implementation of deterministic analytical methods for CCI testing has enabled deeper insight into the performance of primary packaging with respect to CCI. However, ensuring good CCI goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This webinar will describe a framework to enable such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.

Mar 11, 2021 10:30 AM in Eastern Time (US and Canada)

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Speakers

Derek Duncan
Director Product Line @Lighthouse Instruments
Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics in Amsterdam. He moved into industry holding Product & Application Development positions. Currently at LIGHTHOUSE since 2003, Dr. Duncan is responsible for developing applications for process monitoring and finished product inspection.