Insights On Regulatory Compliance

  1. Electronic Batch Reporting 1/22/2024

    Learn how a CDMO automatically created a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures with an Industrial DataOps software solution.

  2. Owen Mumford Slashes Audit Findings, CAPAs, And NCRs 2/7/2025

    Gain insights into how Owen Mumford, a global medical device leader, enhanced their compliance and efficiency with software to reduce audit findings and improve quality management.

  3. Achieving Ophthalmic Production 5/23/2024

    A partner with state-of-the-art facilities can guarantee efficient and scalable production of ophthalmic solutions, drops, and ointments, and is critical as you navigate the complexities of ophthalmic production.

  4. Bioprocess Optimization: Leveraging Functional DOE With Time-Based Insights 3/5/2025

    Explore the key differences between traditional DOE and Functional DOE as Seongjin Kim demonstrates how the latter enhances bioprocess optimization through a fed-batch cell culture example.

  5. The Problems With Construction Quality In Life Sciences 11/7/2023

    In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.

  6. Early Development Considerations For Late-Stage NCE Success – Part One 12/8/2023

    Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.

  7. A Driving Force For Advanced Cleanroom Standards 2/18/2025

    Navigating the inherent conflicts between GMP and biocontainment regulations is critical when designing specialized cleanrooms for advanced therapy manufacturing.

  8. Uncovering The Root Cause Of Clinical Trial Troubles 12/10/2024

    Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.

  9. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

  10. 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.