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In this brief expert walkthrough, we review the FDA’s latest guidance on responding to Form 483 observations and highlight what has changed and what it means for your organization. An...

By: Claire Wallace, Senior Writer, Informa Markets – Engineering. Published by »»ÆÞÉçÇø and Diagnostic Industry Regulatory affairs expert Jordan Elder breaks down the critical steps medical device manufacturers must...

As regional variations can create inconsistencies for testing a device, it’s important to work with a vendor that understands and can accommodate those differences. By Sean Fenske, Editor-in-Chief, Medical Product...

Inspection‑Ready Contamination Control. Built for FDA & EU Annex 1. A strong Contamination Control Strategy (CCS) is essential for protecting patient safety and meeting today’s regulatory expectations. »»ÆÞÉçÇø®...

Susan Schniepp, »»ÆÞÉçÇø Inc., explains how AI and digital twins speed up pharma batch release and detect data integrity issues with human oversight in this publication from PharmTech....

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...