Insights On Regulatory Compliance

  1. Navigating Your Holistic Approach To CCI For Biologic Drug Products 6/12/2024

    Explore regulatory framework and expectations, and see the benefit of a comprehensive approach to CCI tailored for mAbs and complex modalities such as fusion proteins or bioconjugates.

  2. Simplify Cell Line Development 10/1/2025

    Explore a streamlined method for isolating viable single cells using microfluidic dispensing and whole-well imaging that is designed to improve clonality, cell health, and reproducibility.

  3. Five Steps To Implementing CSA 12/17/2024

    Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

  4. Proven Strategies For GxP Compliance And Inspection Readiness 6/23/2025

    Struggling with data integrity challenges? Discover proven strategies for GxP compliance and inspection readiness in this essential webinar. Learn to build a robust framework and avoid common pitfalls.

  5. Accelerate And Enhance Biomanufacturing Operator Training 5/28/2025

    Unlock the power of blended operator training and learn how combining digital tools with hands-on instruction reduces errors, boosts retention, and empowers your workforce for real-world production success.

  6. Use Of Conductivity As A Tool For On-Site Residue Management 3/7/2025

    Residues from cleaning and disinfection are under increased scrutiny in cleanrooms. A new method using conductivity measurements offers a more accurate and objective way to quantify these residues.

  7. Safeguarding Quality In Parenteral Drug Manufacturing 10/16/2025

    Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

  8. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

  9. Ensure Consistency Across Batches With A Powerful Tool 5/19/2025

    Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.

  10. How To Implement Three Cleaning Best Practices For Your Cleanroom 3/28/2024

    Learn about the three cleaning best practices that will make a difference in your cleanroom, the importance of each step, and how to implement these strategies.