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Data Integrity Hotspots As artificial intelligence and digital twins become more integrated into pharmaceutical manufacturing and validation, they are creating new opportunities to improve efficiency, strengthen quality oversight, and accelerate...

The FDA is transitioning the National Drug Code to a standardized 12‑digit format, with the final rule taking effect on March 7, 2033. While the timeline may seem distant, this...

Human factors engineering (HFE), also referred to as usability engineering, is a structured, risk-based process intended to reduce use errors and ensure medical devices are safe and effective for their...

Susan Schniepp, ÃÛ¶¹ÊÓƵ Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and evolving machine learning risks in this publication from PharmTech. Link...

In this video article published by PharmTech, Susan Schniepp says poor quality in pharma manufacturing is costly but catching defects early can saves millions. Link to the Video and Article...

Preventing Pharmaceutical Product Recalls In this episode of Ask the Expert, Susan J. Schniepp of ÃÛ¶¹ÊÓƵ Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss common...