Validation, Commissioning & Design White Papers & Case Studies

  1. Developing Effective Procedures 10/21/2024

    Effective procedure development starts with understanding the purpose and should integrate change management, risk management, and knowledge management to ensure a robust quality system.

  2. 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."

  3. 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.

  4. Solving The Silicone Challenge In Pre-Fillable Syringes 8/27/2024

    Discover a technology platform that is revolutionizing the pre-fillable syringe market by solving the challenge of silicone sensitivity, ensuring stability for sensitive drugs.

  5. CMO Validation As A Service 8/20/2024

    Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

  6. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.

  7. Quality By Design: The Importance Of Reference Standards In Drug Development 8/1/2024

    Learn more about the comprehensive lifecycle management of reference standards, encompassing qualification, characterization, and storage procedures.

  8. What Changes When Your CPV Goes Digital 7/10/2024

    Explore the advantages of digitalizing Continued Process Verification (CPV) through the experience of a pharmaceutical company step-by-step.

  9. Bypassing The Challenges Of Paper-Based Validation 7/10/2024

    Gain insight into why a biotechnology startup and CDMO views investment in a digitized validation lifecycle management system as crucial for accelerating innovation and reducing time to market.

  10. Best Practices In Commissioning And Qualification 7/5/2024

    An integrated approach to C&Q ensures coordination and synchronization between commissioning and qualification activities, enhancing both regulatory compliance and product safety.