Insights On Regulatory Compliance

  1. Measuring And Monitoring Environmental Surface Residues 4/1/2025

    Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation.

  2. Validation Provider Shortens The Path To Equipment Qualification 8/19/2025

    Explore the partnership enabling Transcat to meet regulatory requirements while focusing on core R&D and accelerating the delivery of life-changing therapies.

  3. Compliance: Framing Success Utilizing PIC/S And EU GMP 12/20/2023

    Explore the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and gain insight into the teamwork between the FDA, MHRA, and PIC/S.

  4. GMP Calibration Management 8/8/2025

    Learn why generic EAM systems fall short in regulated industries and how purpose-built solutions ensure compliance, efficiency, and audit readiness.

  5. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

  6. Leverage Apps To Reduce Line Changeover Time From 14 Days To 3 6/26/2025

    A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

  7. How Process Intensification Supports A Sustainable Future 7/1/2025

    Discover how process intensification is revolutionizing bioprocessing by boosting efficiency and reducing waste. Hear from experts on how these innovations are driving a more sustainable future.

  8. Development Of A Non-Standard Protein Therapeutic 9/9/2025

    Discover how a tailored development approach transformed a complex therapeutic protein into a candidate ready for early-stage clinical trials.

  9. 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.

  10. 4 Conversations To Drive Your Business Case For Digital Validation 3/19/2025

    Change in life sciences is challenging due to strict regulations, high stakes, and the importance of patient safety. Learn how to advocate for digital validation workflows through four key conversations.