Insights On Quality Assurance

  1. Regulatory And Quality Consulting, Operational Readiness Services 10/5/2023

    Learn how CAI aided a manufacturing company in merging food regulations with biopharmaceutical technology, allowing for the quick conversion of a small R&D facility into a GMP-compliant facility.

  2. 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.

  3. Closing The 'Knowing-Doing' Gap In R&D Using USP <1062> Data 7/24/2023

    Data acquisition system tools have come a long way and now you can learn which trial runs will help you generate the most valuable data.

  4. 5 Key Elements Of Quality By Design In Pharma 9/20/2024

    Learn about the advantages of embedding quality throughout design and manufacturing, explore five practical elements of QbD in pharmaceuticals, and discover how a QMS can support QbD.

  5. Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market 2/2/2024

    Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so it continues to meet users’ needs.

  6. Using PIMS To Leverage Your MES Data For Process Lifecycle Insights 12/28/2023

    Get the most out of your MES data by asking the right questions and preparing for the future of MES in the BioPharma industry.

  7. Transforming Quality Processes And Collaboration 4/16/2024

    Learn how a global CDMO improved efficiency, visibility, and collaboration by standardizing quality procedures and expanding them to external partners.

  8. Training Solutions To Optimize Quality And Compliance 4/16/2024

    Discover the advantages of integrating content and document management into a single system to create efficiencies and oversight while improving employee training.

  9. A New Framework For Identifying Nitrosamine Risks And Efficiently Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  10. Nitrosamine Impurities Deadline: Are Your Products Compliant? 11/6/2023

    The FDA nitrosamine contamination guidance set deadlines of Nov. 1, 2023, for risk assessment updates and Aug. 1, 2025, for full NDSRI limit compliance.