Resources

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, Regulatory 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...

In this episode of Ask the Expert, published by PharmTech. Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls. Link to the Video and Article...

Why Cybersecurity Has Become a Regulatory Priority As combination products increasingly rely on software, connectivity, and digital interfaces, cybersecurity has moved from a secondary concern to a core regulatory expectation....