Inspection

  1. Survival Kit For Quality Regulations: A Closer Look At Lyo Packaging

    Explore primary packaging developed following well-established ICH principles for sustainable compliance and vial container closure systems for product development and commercial manufacturing needs.

  2. Selecting Container Closure Systems With Confidence: Lyophilization 3/7/2024

    Experts take you through the entire selection process for primary packaging components for lyophilization and provide aspects to consider for all relevant attributes.

  3. A Science-Based Approach For Ensuring Container Closure Integrity Of Sterile Vials 3/15/2021

    Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity (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.

  4. Container Closure Integrity Of Product Requiring Deep Cold Storage 8/26/2022

    Gain insight into the risk to container closure integrity (CCI) during deep cold storage and identify appropriate analytical tools, to generate robust data to characterize and mitigate the risk to CCI.

  5. A Practical Road Map For Compliance To EU GMP Annex 1

    Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.