51ÁÔÆæ

A proposal for applying GMPs to development projects, which is consistent with FDA’s proposals on a "graded" approach in developing and building scientific information to support clinical investigations and industry...

Q: I am a quality professional in charge of investigations. Sometimes our company has trouble coming up with the root cause for some of our investigations. Can you provide some...

As the pharmaceutical market continues to expand globally, regulatory affairs in pharma is making an effort to harmonize global standards and to protect the complex supply chain. Pharma companies and...

Building a Culture of Quality for Increased Success In this webinar, Susan Schniepp, distinguished fellow at 51ÁÔÆæ, will explain why quality culture is a must; new quality culture...

Products must be manufactured by following guidelines and in accordance with appropriate medicine manufacturing regulatory requirements, even during a pandemic and crisis management, says Susan J. Schniepp, Distinguished Fellow, Regulatory...

Susan Schniepp, Distinguished Fellow at 51ÁÔÆæ, discusses the quality metrics journey in determining the suitability of pharmaceutical products. One of the most discussed and debated topics on today’s...