On-Demand Webinars

31. Managing Nitrite Impurities: Supplier-Manufacturer View 12/19/2024

    Examine nitrites in excipients, nitrosamine risks, regulatory considerations, analytical controls, and a case study on mitigating risks in pharmaceutical manufacturing and storage.

32. How Standardized Extractables Data Support E&L Risk Assessment 12/19/2024

    Explore E&L evaluations, USP <665>, supplier-provided extractables data, and collaborative strategies to mitigate risks in Single-Use Systems for biopharmaceutical manufacturing processes.

33. Evaluating USP 665 For Extractables Testing And Reducing Animal Testing For Biological Reactivity 12/19/2024

    Explore evolving compendial methods, USP <665>, and transitioning to cell-based assays for extractables, leachables, and biological reactivity in single-use pharmaceutical manufacturing.

34. Challenges Using Multiple Single-Use Systems Functionality Versus Extractables And Leachables 12/19/2024

    Explore a risk assessment of extractables, evaluating single-use components, and addressing complexities in manufacturing processes, with a case study highlighting compatibility and patient safety concerns.

35. 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.

36. Unlocking Audit Success: Navigate Compliance With Confidence 12/17/2024

    Watch expert Kathianne Ross explore ALCOA+ principles, audit preparation strategies, and the role of digital validation in enhancing compliance and audit success.

37. Rapid Process Development And Technical Support For AAV Scaleup 12/17/2024

    Accelerate your AAV production journey. Learn how rapid process development and expert support can streamline your path from vial to purified bulk, ensuring scalable and efficient manufacturing.

38. Accelerate Production Through Digital Commissioning And Qualification 12/17/2024

    Watch to learn how digital validation streamlines commissioning and qualification (C&Q), improving productivity, compliance, and cost-efficiency across your organization.

39. mAb Up- And Downstream Process Intensification Strategies 12/12/2024

    Discover how to reduce monoclonal antibody (mAb) manufacturing time and costs through process intensification. Learn about continuous perfusion, ultrahigh cell density banks, and more.

40. Project Delivery Methodology To Accelerate Operational Readiness 12/11/2024

    Learn how to implement a focused operational readiness model that goes beyond traditional construction and startup schedules. Discover how this approach can reduce timelines and improve project success.