INSIGHTS ON QUALITY ASSURANCE

• PUPSIT Without The Pain: Practical Solutions For Implementation

  Explore the critical role of pre-use post-sterilization integrity testing in quality risk management, as well as learn about integrity testing, wetting procedures, and innovative filtration systems for effective implementation.

• Aiming For Success In Early mAb Process Development And Beyond

  Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

• Digital Maturity In Life Sciences Quality And Manufacturing

  Innovators in life sciences manufacturing drive life-saving breakthroughs. Amid strict regulations and complex challenges, learn how your dedication ensures quality and pushes the boundaries of what’s possible in public health.

• Advanced Aseptic Filling Assembly Helium Integrity Testing

  Helium leak testing offers unmatched sensitivity for detecting micro-leaks in single-use fill-finish systems. Learn how tighter leak thresholds can strengthen aseptic processing and regulatory confidence.

• A Data-Driven Approach to Cleaning Validation

  10/21/2024

  Discover how Ongoing Process Verification, guided by PAT and digital integration, ensures consistent cleaning efficacy, reduces risks, and optimizes production efficiency in the pharmaceutical industry.

• Ensure Sterility In Small-Batch Drug Production

  1/9/2026

  Automation and sterility are critical for small-batch drug manufacturing. Learn how robotic isolators streamline vial filling, reduce contamination risk, and support advanced therapies with precision.

• Predicting Performance Of Lotions Through Rheological Characterization

  5/6/2026

  Rheological testing shows how small formulation differences influence spreading, flow, and feel during use. With minimal sample volumes, these methods connect lab measurements to real‑world performance.

• Product-Wet Integrity Testing: Risk-Based Strategies

  5/22/2026

  When standard water‑based integrity testing falls short, product‑wet approaches can offer a more representative alternative. Learn how risk‑based strategies are used to establish reliable test limits.

• 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.