Inspection‑Ready Contamination Control. Built for FDA & EU Annex 1. A strong Contamination Control Strategy (CCS) is essential for protecting…
Susan Schniepp, Regulatory Compliance Associates Inc., explains how AI and digital twins speed up pharma batch release and detect data…
Susan Schniepp, Regulatory Compliance Associates Inc., discusses digital twins and AI in pharma, focusing on data integrity, human-in-the-loop roles, and…
In this video article published by PharmTech, Susan Schniepp says poor quality in pharma manufacturing is costly but catching defects…
In this episode of Ask the Expert, published by PharmTech. Susan J. Schniepp and Siegfried Schmitt discuss how companies should…
Explore how to collaborate effectively with regulators to develop orphan drugs, including strategies for regulatory engagement, incentives, and approval pathways.
Learn how to expand your pharmaceutical quality management system to support combination product development, compliance, and inspection readiness.