Insights On Regulatory Compliance

  1. Easy Integration Of A New Manufacturing Platform 6/11/2025

    Easily integrate an innovative platform into your manufacturing process with seamless onboarding, regulatory support, and expert guidance that is designed to help you confidently adopt good manufacturing practices.

  2. Regulatory Considerations Including Extractables & Leachables For Single-Use Manufacturing 10/29/2024

    Watch to gain insights into regulatory guidance for single-use manufacturing and risk assessment strategies for single-use implementation.

  3. ISO Cleanroom Standards 6/24/2025

    Explore how ISO 14644 and EU GMP Annex 1 shape cleanroom standards, with a focus on particle control, system accuracy, and the surprising impact of tubing length limitations.

  4. Understanding Biosafety Levels 5/20/2024

    Compliance with biosafety levels (BSLs) is crucial in ensuring that your laboratories meet stringent standards to protect staff and prevent the escape of biological agents.

  5. Tips For Viral Vector Production 4/16/2024

    Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.

  6. Digital Solutions For Accelerated Innovation 5/19/2025

    In this webinar, hear how Applied Biosystems AccuSEQ software serves as an advanced digital tool that can help streamline bioanalytical processes and accelerate the delivery of life-changing therapies.

  7. Optimal Microbial Sampling Criteria 6/24/2025

    Microbiological sampling ensures sterile conditions through surface, passive, and active air methods. The EU GMP Annex 1 emphasizes integrating these for comprehensive environmental monitoring.

  8. Critical Considerations For Buffer Preparation 8/7/2023

    Learn about the steps of buffer development, supply approach and strategy selection, choosing between in-house and outsourcing buffer activities, and other related buffer use topics.

  9. Overview Of Biological Indicator And Sterilization Monitoring Systems 7/2/2024

    Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.

  10. Driving Continuous Improvement: Pushing Through The Barriers To Change 10/15/2024

    Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.