Insights On Regulatory Compliance

  1. What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry? 8/1/2024

    The revised Annex 1 focuses on harmonizing regulations across the pharmaceutical manufacturing industry, prompting the pharmaceutical industry to strategize to achieve the best compliance method.

  2. The Bumpy Road Ahead: Stakeholder Perspectives On EU HTAR 1/17/2025

    Experts convened at ISPOR Europe 2024 to discuss the upcoming EU Health Technology Assessment Regulation (EU HTAR), sharing insights and lessons learned from recent national reforms.

  3. The Future Of Compliance, Efficiency, And Data Integrity 5/5/2025

    Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

  4. Avoiding The Pitfalls Of PQR 10/9/2024

    Explore the fundamentals of Product Quality Reviews (PQRs), common challenges manufacturers face, strategies for streamlining PQRs, and solutions that aim to unlock the potential of a "real-time PQR."

  5. Developing A Comprehensive Regulatory Approach For LNP Drugs 2/26/2024

    The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

  6. Closed Sampling: Crucial For Aseptic Processing 6/26/2025

    Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.

  7. MilliporeSigma's 97-Day Implementation Success Story 3/19/2025

    Discover how MilliporeSigma transformed validation processes with a digital validation system to achieve efficiency and compliance in just 97 days as well as learn key takeaways from their swift transition to digital validation.

  8. Navigating Cleanroom Compliance For Safe Material Transfer 7/23/2024

    Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.

  9. Implementing A Risk-Based Approach To Calibration 2/20/2024

    Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

  10. Guide To Pharmaceutical CAPA And Quality Management 3/14/2025

    CAPA management is vital for quality systems, especially in pharmaceuticals. Examine how issues are identified, corrected, and prevented to safeguard health and uphold regulatory compliance.