Featured Pharma Online Editorial

  1. From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations 4/6/2026

    Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.

  2. From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations 4/1/2026

    The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.

  3. Generative AI Can Write The Code, But Who Builds In The Quality? 3/23/2026

    Code democratization demands a return to the fundamentals of quality in pharmaceutical and regulated environments.

  4. Raising The Bar In Radiopharmaceutical Manufacturing 3/12/2026

    Ratio Therapeutics' chief commercial and manufacturing officer, Scott Holbrook, joined me to discuss how his team at Ratio Therapeutics is tackling the challenges of radiopharmaceutical manufacturing.

  5. The U.S. Has A New Vice To Squeeze Foreign Imports: Pharma Quality 2/13/2026

    The Trump administration has effectively merged national security, trade policy, and drug quality. Now, foreign manufacturers lacking deals face paying a "quality tax."

  6. Top 7 AI Lessons Learned 12/23/2025

    As an icebreaker to start the panel, Teresa Minero from LifeBee asked each presenter to share their top recommendations and major issues to avoid with AI.

  7. An AI Use Case in Pharma Process Optimization 12/18/2025

    Recordati Ireland’s production coordinator Ross Fitzgerald took attendees through his team’s AI journey, from identifying the problem to using AI data analytics to find a solution.

  8. Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis 12/17/2025

    Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.

  9. Leveraging Historical Data To Accelerate Process Understanding 12/5/2025

    At the ISPE Annual Meeting & Expo, I had the chance to sit in on a presentation by Philippe Cini, partner for A-Connect, who introduced his data-focused method of process understanding to recognize defects early, make process changes quickly and stay on schedule.

  10. Fostering A Quality Software Culture 11/24/2025

    Transforming the quality culture should include the adoption of software quality engineering (SQE), but what is it, and how can it impact the quality of your products and processes?