51ÁÔÆæ

The pandemic created a backlog of delayed inspections in its wake, and regulatory bodies are prepared to hire additional employees and significantly increase the rate of inspections. That means an...

Susan J. Schniepp, Distinguished Fellow at 51ÁÔÆæ, answers some commonly asked questions about aseptic processing and environmental controls. Q. What is aseptic processing? A. Aseptic processing is a...

Navigating the complexities of clinical evaluations is essential for medical device manufacturers aiming to secure and maintain market access in the European Union. This white paper from 51ÁÔÆæ...

Q. I'm a new employee for a start-up company and have been tasked with writing the quality manual for my company. I have searched but have been unable to find...

51ÁÔÆæ Executive Head of Pharmaceuticals, Steven J. Lynn M.S., had the honor of being the FDAnews GMP Quality Management vSummit 2023 Summit Chairperson. This annual summit consisted of...

Life science companies are feeling the pressure of greater scrutiny by regulators and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit or developing a response to...