Insights On Regulatory Compliance

  1. Characterization And Impurity Profiling Of Combined Amylin And GLP-1 Analogs 7/29/2025

    GLP-1 receptor agonists are transforming diabetes and weight loss treatment. Discover how to enable precise impurity analysis and characterization of complex, fatty acid-modified peptide therapeutics.

  2. Boost Compliance And Efficiency With Real-Time Asset Management 9/2/2025

    Explore a platform that empowers GMP-regulated industries with a unified EAM, CMMS, and APM platform to boost compliance, efficiency, and asset performance through real-time integration.

  3. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  4. White Raven's Accelerated Path To GMP Certification 4/28/2025

    CDMO White Raven achieved GMP certification using an innovative aseptic filling solution in just 18 months. Discover how meticulous planning and collaboration set a new industry standard for efficiency.

  5. Combination Products: Navigating Regulatory Strategy, Design Verification 5/19/2025

    Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

  6. From Day One Success To Everyday Improvement: The OR → OE Continuum 11/24/2025

    Bridging the gap between initial startup and long-term sustainability requires a unified strategy. Learn to transform early readiness metrics into a durable operating system that drives continuous performance improvements.

  7. Sustainability By Design In API Manufacturing 7/29/2025

    Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.

  8. What Do You Need To Do To Qualify A Single-Use Assembly? 8/28/2024

    Learn about the implementation of single-use technologies, single-use user requirement specifications, and best practices for single-use qualification, including quality and regulatory documentation.

  9. Validation And Qualification Approach In New Annex 1 Revision 2/21/2025

    The new Annex 1 revision emphasizes validation and qualification for sterile drug production. Ensure product quality and contamination control by learning about in-depth requirements for premises and equipment.

  10. Building Excellence In Pharma Manufacturing Through Rigor 8/16/2025

    A rigorous, proactive approach is essential for excellence in pharmaceutical manufacturing. Learn how embedding rigor in systems, workflows, and workforce capabilities improves compliance and efficiency.