News, Events and Insights

New Guidance issued by FDA on Quality Metrics

New Guidance issued by FDA on Quality Metrics

On September 9th, 2016 FDA released a technical reference document aimed at quality metrics in process validation and the pharma quality systems.   The goal of this document, per the FDA,…

The Cleanroom of the Future

By Jeanne Moldenhauer Vice President at Excellent Pharma Consulting   At a local Northeast PDA meeting on 5/18/16, over 130 attending, eleven BSM colleagues attended a great meeting where the…

Assessing Risk in Sterile Manufacturing

By Andrea Wagner, Ph.D. SVP, Business Development, Berkshire Sterile In a recent training at Berkshire Sterile, the topic of risk assessment was covered. This topic is a very important one…

From Pharma Kongress in Dusseldorf, Germany

By Andrea Wagner, PhD, SVP, Business Development This week I had the pleasure of attending Pharma Kongress in Dusseldorf where there were a wide variety of talks given on pharmaceutical…