Insights On Regulatory Compliance

  1. 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.

  2. ICH Guidelines: Challenges And Solutions For Pharma Manufacturers 10/8/2024

    Take the next step in enhancing your pharmaceutical manufacturing processes by investing in a robust quality management system (QMS) designed for ICH compliance and operational excellence.

  3. Custom Mobile Pharmacy Cleanroom Trailer For Oncology Infusion Pharmacy Services 6/26/2024

    Gain insight into the mobile cleanroom that was created to accommodate the needs of Moffitt Cancer Center's Oncology Infusion Pharmacy Services and adhere to USP <797> and <800> standards.

  4. The Role Of IV Bag Inspection In Drug Manufacturing 2/5/2025

    Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.

  5. How Recent Trends Impact Bringing Your Molecule To Market 7/9/2024

    With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.

  6. 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.

  7. Resource Savings Through Effective Global Trade Compliance 5/16/2024

    Ensure consistent planning, accurate cost estimation, and enhanced delivery timelines for materials shipped across borders by partnering with a CDMO equipped with a dedicated trade compliance team.

  8. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  9. Safety & CQAs: Do mRNA Therapeutic Regulators Know What They Want? 12/5/2023

    In this segment, Combined Therapeutics CSO Thomas Van Cott, Ph.D. and Omega Therapeutics Executive Director, Process Development and Analytical Sciences Jeff Atkinson, Ph.D. address regulators’ likely safety and CQA concerns as well as audience questions regarding variable and changing RNA constructs.

  10. ICH Q2 And ICH Q14 Revisions Clarify Analytical Methods For Biologics 8/30/2024

    Learn about the revisions to ICH Q2 and Q14 that provide clarification on analytical methods for biologics, aiming to ensure accuracy, reliability, and consistency in testing these products.