Inspection

1. 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.

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. 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.

4. 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.

5. USP <922> Water Activity Testing For Oral Solid Dose Pharmaceuticals 8/26/2022

   Gain insight into the technical and regulatory justification for adding water activity measurements into pharmaceutical stability protocols.

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. 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.

8. Container Closure Integrity Testing Method Development

   Dr. Derek Duncan, Director of Product Lines, Lighthouse Instruments, covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

9. 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.

10. New Guidelines For Container Closure Integrity Testing 12/20/2018

    Increased regulatory scrutiny and exciting new analytical technologies have altered the landscape of container closure integrity testing. In order to provide guidance to this new environment the US Pharmacopoeia revised Chapter <1207> Sterile Product Package Integrity.  View this webinar recording to learn about the new guidelines and how they will impact your approach to sterile product package integrity.