Insights On Quality Assurance

  1. CAPA Management Improvement Process 9/15/2023

    Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.

  2. Protecting CAPEX Budgets Through Digital Validation 9/9/2025

    Streamline your CAPEX validation to accelerate growth, reduce costs, and bring your product to market faster. Discover how futureproof digital validation can protect your budget and maximize value.

  3. Digital Transformation In Contract Manufacturing: A Leadership Perspective 5/13/2025

    Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

  4. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

  5. Process Intensification: Your Guide To "Doing More With Less" 8/5/2025

    Explore innovative strategies in process intensification to boost mAb production and hear from industry experts as they share solutions for scaling efficiency and navigating regulatory challenges.

  6. 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.

  7. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  8. Your Environmental Monitoring Can't Be Your Only Line Of Defense 9/1/2025

    Environmental monitoring (EM) is essential, but it’s only part of the picture. Discover why a proactive contamination control strategy is key to keeping your cleanroom truly audit-ready.

  9. Choosing A PCD Configuration For Your Cycle 8/15/2025

    Ethylene Oxide (EO) sterilization is essential for medical device safety. Explore how Process Challenge Devices help validate and monitor EO processes with precision across a wide range of applications.

  10. ICH Quality Risk Management Guidelines For Biopharma Manufacturing 11/27/2023

    Explore the key changes to the ICH Quality Risk Management guidelines that aim to optimize efficiency, effectiveness, and scientifically grounded control strategies.