Insights On Regulatory Compliance

  1. Environmental Monitoring For Aseptic Filling 3/6/2025

    Explore regulatory interest in modern environmental monitoring for aseptic filling, the benefits of biofluorescent particle counters, and their role in enhancing drug product safety and quality.

  2. The Future Of GxP Manufacturing With AI 4/21/2025

    Discover how to digitize batch records in just 180 days with Christian Gay Porcel by leveraging AI for automated compliance and scalable validation.

  3. How Digital Innovation Can Inform RWE-Led Decision-Making 1/17/2025

    Real-world evidence (RWE) is changing how healthcare products are developed and marketed. Learn how digital innovations are helping companies leverage RWE to make better decisions.

  4. How To Solve The Big Challenges Of Cell And Gene Therapy Manufacturing 7/24/2025

    Cell and gene therapies are revolutionizing medicine, but outdated manufacturing methods are slowing progress. Discover how modernizing CGT production can unlock the full potential of life-changing treatments.

  5. Adapting To Evolving Regulations: Validation In A Changing Landscape 3/26/2025

    Discover how evolving regulatory expectations in life sciences present new challenges and opportunities, as well as gain insight into strategies from experts in the field to navigate risk-based validation processes.

  6. Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections 12/20/2023

    Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

  7. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

  8. Three Key Strategies To Guide Efficient And Effective Recall Management 2/18/2025

    Discover how to successfully navigate recalls with a digital approach that helps achieve effective recall management, communication, and continuous improvement for brand integrity.

  9. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  10. Visualizing Airflow With Smoke Studies For Aseptic Manufacturing Excellence 7/7/2025

    JHS uses smoke studies to visualize airflow in cleanrooms, ensuring aseptic conditions and regulatory compliance for sterile pharmaceutical production, especially on new aseptic filling lines.