Inspection

1. 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.

2. Early-Stage Considerations For The Selection Of Pre-Fillable Syringes When Developing A Vaccine 5/14/2021

   Get an overview of the strategy to speed up the migration from a vial to a pre-fillable syringe. Explore the main considerations in meeting and overcoming PFS-drug challenges when developing a vaccine.

3. The Container Closure Integrity Requirements In The Revised EU Annex 1

   Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

4. Protecting Oxygen Sensitive Formulations Throughout Product Life Cycle 5/19/2021

   This webinar reviews how oxygen levels in finished parenteral drug containers can be determined and controlled throughout the product life cycle by using laser-based headspace analysis.

5. Replacing Total Moisture Measurements By Water Activity Determination 4/19/2022

   This short video explains the difference between total moisture content, headspace moisture, and the relation to water activity.

6. 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.

7. USP <922> Water Activity Has Opened A Door For OSD Manufacturers 6/20/2022

   Learn more about USP <922> Water Activity and why using Karl-Fischer titration to measure total water content is no longer adequate to fully understand the stability of oral solid dosage products.

8. A Rapid Approach For Moisture Determination Of Lyophilized Product 11/13/2024

   Explore the limitations of traditional moisture determination techniques, an innovative approach using laser-based headspace analysis, and real-world case studies using this non-destructive method.

9. Rapid Non-Destructive Product Moisture Determination In Stability Studies 2/17/2022

   Examine whether Karl-Fischer (KF) titration can be replaced by rapid, non-destructive lyo product moisture determination method.

10. Why Add Water Activity To The Stability Test Protocol 3/21/2022

    In this video we describe a framework on how by adding water activity measurements to stability protocols will achieve to improve the quality program.