ARTICLES BY KATIE ANDERSON
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Top 7 AI Lessons Learned12/23/2025
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.
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An AI Use Case in Pharma Process Optimization12/18/2025
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.
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It's Copy/Paste In Fleet Management Manufacturing12/11/2025
Copy and paste may be frowned upon in most work tasks, but not in the case of “fleet management.” In the past few years, Roche and Novo Nordisk collaborated to introduce this concept of applying the copy/paste action to standardized, decentralized facilities.
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Leveraging Historical Data to Accelerate Process Understanding12/5/2025
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.
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Høeg In, Pazdur Out At The FDA12/4/2025
What an eventful week it has been at the FDA, with Richard Pazdur, M.D., resigning after weeks in his position as director of Center for Drug Research and Evaluation (CDER), and his vacancy being quickly filled by acting director Tracy Beth Høeg, M.D.
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Fostering A Quality Software Culture11/24/2025
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?
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Is Charisma An API?11/19/2025
After nearly 20 years in the pharmaceutical industry, Samir Shah, director of regulatory CMC for medical products and combination products at AstraZeneca, knows how beneficial charisma can be for the pharmaceutical professional. That’s why he presented the topic at the 2025 RAPS Convergence.
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3 Ways To Deliver A Pharma 4.0 Facility11/17/2025
O’Callaghan supplied three ways in which Sanofi brought its sites to the modern era, which were supported throughout the event’s presentations
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Innovation, Growth (and Happiness) Projected for Pharma11/10/2025
Not only is investment increasing in pharma, but innovation is propelling growth in multiple drug segments, and the people supporting this growth and innovation remain happy.
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Shaping The Future Of GLP-1 Quality11/4/2025
Three experts—Doug Bakan (CTO of Kailera), Hyung Heon Kim (CEO of MetaVia) and Deepa Nagpal (Founder of SygnifyQ)—joined us on Oct. 15, 2025, to explore this topic, find out the most common quality failures, learn what innovation is occurring and find out what business decisions can help support both quality and quantity.