INSIGHTS ON QUALITY CONTROL

• Physical Contamination Detection

  Learn how physical contaminants enter production lines and how detection systems like metal detection and X-ray inspection help prevent defects and recalls to strengthen quality control.

• Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance

  Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

• CMO Validation As A Service

  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.

• Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC

  Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.

• The Future Of QC Is Now

  5/5/2026

  Pharma Industry 4.0 is reaching microbiological quality control. See how automation and digital workflows are transforming manual QC processes, improving productivity, and reliability.

• Software Simplifies 21 CFR Part 11 and Annex 11 Compliance

  12/9/2024

  21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

• Robust, High-Throughput Automated Solution For Water Endotoxin Testing

  4/21/2026

  High-throughput water endotoxin testing doesn’t have to sacrifice consistency. Gain insight into how an automated workflow delivers reliable results, low variability, and strong control recovery.

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  12/8/2025

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• Integration Of Container Closure Integrity In Contract Manufacturing

  3/28/2025

  Maintaining drug product sterility and compliance demands rigorous Container Closure Integrity (CCI) within contract manufacturing. Learn how to fortify your processes.