Quality Assurance

1. Airflow Visualization Studies: The Impact Of Annex 1 On Sterility Assurance 12/18/2024

   Airflow visualization techniques like Smoke Studies and CFD analyses are crucial for contamination control, aiding cleanroom qualification, environmental monitoring, and optimizing contamination control strategies under Annex 1.

2. Meet The Experts: Part 1 - Process Analytical Technology (PAT) 5/1/2023

   Watch part 1 of this 4-part interview series to learn about process analytical technology (PAT) from expert Stacy Shollenberger.

3. Meet The Experts: PAT, Raman Spectroscopy, And Chemometrics 4/14/2023

   Gain a better understanding of process analytical technology (PAT), Raman spectroscopy, chemometrics, and Raman applications in bioprocessing.

4. Using Positive Controls In Container Closure Integrity Studies 1/2/2019

   This webinar describes the use of positive controls as an important element of CCI studies designed to validate packaging components for CCI or to qualify processes for producing good CCI.

5. Revolutionizing Contract Manufacturing With A Unified QMS And MES Platform 11/4/2024

   Watch to gain expert insights on utilizing a closed-loop, single-platform approach and explore practical examples and data showcasing the advantages of integrating your QMS and MES.

6. Determining And Controlling Oxygen Levels In Sensitive Formulations 1/2/2019

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

7. Overcome The Hidden Complexities Of mRNA Process Development 3/22/2023

   Explore the challenges behind the perceived simplicity of mRNA process development, as well as characterization strategies and models for predicting process outcomes at early stages.

8. CCI Testing And Revisions To EU Annex 1 1/2/2019

   The new language in EU Annex 1 will likely have a significant impact on your CCI testing practices. In this webinar CCI testing strategies and the proposed revisions to EU Annex 1 are discussed.

9. 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.

10. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.