Insights On Regulatory Compliance

  1. Sustainable Solutions For Medical Devices 1/6/2025

    Explore how medical device companies aim to balance patient safety with environmental stability by offering bio-based UHMWPE, which reduces carbon footprints by up to 70%.

  2. How To Easily And Quickly Monitor Cleanrooms 5/6/2024

    Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.

  3. State Of Validation Report 2024 12/17/2024

    Explore trends in compliance, audit readiness, digital systems, process efficiencies, emerging KPIs, and the adoption of Pharma 4.0 technologies.

  4. 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.

  5. Nitrosamine Testing For Regulatory Readiness 7/8/2025

    Discover how delivering ultra-sensitive detection of nitrosamine impurities like NDMA and NDEA helps safeguard pharmaceutical quality and meet evolving global regulatory demands.

  6. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

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

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

  8. Unlocking Audit Success: Navigate Compliance With Confidence 12/17/2024

    Watch expert Kathianne Ross explore ALCOA+ principles, audit preparation strategies, and the role of digital validation in enhancing compliance and audit success.

  9. Optimizing CAPA For FDA Recall Success: A Roadmap For Life Sciences Quality Professionals 12/27/2024

    Discover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

  10. 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.