Insights On Quality Assurance

  1. 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."

  2. Harnessing Digitalization In Legacy Pharmaceutical Manufacturing 10/21/2024

    Digital technologies are revolutionizing cleaning validation in decades-old pharmaceutical facilities. Learn about innovative non-intrusive methods to overcome the digital divide in legacy equipment.

  3. Early Development Considerations For NCE Success: Quality Systems 3/1/2024

    Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.

  4. The Transformational Impact Of A Digital Backbone 10/4/2024

    Relying on fragmented data becomes problematic when teams need to dissect cell line performance data and that data is not in a digital backbone.

  5. Insights And Strategies For GMP Manufacturing Of RNA-Lipid Nanoparticles 4/25/2024

    The emergence of RNA-encapsulated-lipid nanoparticles has introduced a seismic shift in biopharma innovation. But how will the industry adapt to diversifying applications and scales going forward?

  6. Vaccine Journey: Bench To Market 7/19/2023

    Vaccines are entering a new era. Gain insight into the market trends, projections, challenges, and potential solutions around the future of vaccine manufacturing.

  7. The Future Of GxP Manufacturing With AI 4/21/2025

    Discover how to digitize batch records in just 180 days with Christian Gay Porcel by leveraging AI for automated compliance and scalable validation.

  8. 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.

  9. Design Testing Strategies To Develop A Drug-Device Combination Product 8/27/2024

    Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

  10. Software Validation Keeps GxP Systems Current, Speeds Up Time-To-Market 2/2/2024

    Requirements to maintain a GxP environment mean researchers must conduct software validation on any updated software so it continues to meet users’ needs.