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Implementing Process Validation Guidances
By Peter H. Calcott, Ph.D., President, Calcott Consulting LLC
Published March 6, 2013
Complying with FDA and EU for small and mid-sized companies Read More »
Published February 27, 2012
Establishing, through documented evidence, a high degree of assurance that a specific process will consistently yield a product that meets predetermined specifications and quality characteristics.… Read More »
Aseptic Process Validation
By Tom Spurgeon
Published November 3, 2006
Is a new FDA guidance imminent? Read More »
By Shamik Pandit
Published August 23, 2005
How the DOE approach can smooth the process Read More »
Patheon
By Kelly Ormsby
With a commitment to quality, scientific excellence and exceptional customer experiences, Patheon is the world's leading provider of contract drug development and manufacturing services. Through an integrated global network of facilities, we give… Read More »
By Bob Forner, Marketing Manager
Siegfried
By Sandy Cernick, Vice President Key Accounts, Exclusives & Marketing, USA
Expect more with Siegfried as your preferred partner. Siegfried offers both drug substance & drug product custom development & manufacturing, and its own product portfolio. Chemical manufacturing cGMP sites are located in Zofingen, Switzerlan… Read More »
By Rose Hawkins, Sales Admin. Supervisor


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