INSIGHTS ON QUALITY CONTROL

• Good AI Practice In GxP: 4 Implications Of FDA/EMA's Joint AI Principles

  See how quality, validation, and IT teams can prepare for the next generation of AI governance in regulated manufacturing. 

• Straight From The Source: A Live Q&A With The Inventors Of KinetiSol™

  Experts discuss a solvent-free fusion process for amorphous solid dispersions, highlighting formulation flexibility, scale-up, process control, and early strategies to reduce risk and support commercialization.

• Predicting Drug-Loading Limits In Tablet Formulations

  Learn how predictive percolation modeling identified critical drug-loading limits of ~20% for crystalline API and ~15% for SDD forms, cutting tablet formulation trial-and-error significantly.

• FDA's Risk-Based Inspection Shift: What It Actually Rewards

  FDA’s revised pre-approval inspection program prioritizes risk-based determinations over routine site visits. Review risk assessment factors and transition toward continuous audit readiness.

• Quality Engineered: The Power Of QbD

  9/23/2026

  How can manufacturers improve process control and flexibility? Explore the benefits of combining QbD with mechanistic modeling.

• Material Transfer Into A Cleanroom: How To Reduce Contamination Risk At Every Step

  4/20/2026

  Evaluate packaging integrity and master wiping techniques to prevent cleanroom contamination. Focus on surface coverage and controlled transfer paths to ensure consistent product safety and quality.

• Controlling Nitrosamine Risk In Drug Products: Detection, Formation, And Control Strategies

  7/31/2026

  Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.

• Delving Into Gene Expression Data Analysis And Experimental Reproducibility

  3/5/2026

  Scientific reproducibility is essential for credible research. Learn to navigate standardized frameworks, refine normalization techniques, and ensure your data remains transparent and verifiable.

• Compressed Gas Risk Assessment: A Significant Step In Your CCS

  10/10/2024

  Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.