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Published November 4, 2014
New analytical lab will focus on analytical quality control testing Read More »
Published April 3, 2014
Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act Read More »
Going Beyond cGMP: Good for Business
By Gerard Creaner, Get Reskilled
Published March 7, 2014
Take a meaningful step to build a quality culture — from the shop floor up. Read More »
FDA’s Quality Agreement Guidance Vs. EMA’s cGMP Regulations
By John Avellanet, Cerulean Associates LLC
Published October 9, 2013
Can you comply with both? Read More »
Published June 4, 2013
Expands capabilities to regulated clients Read More »
By Heather Banuelos, Hunton & Williams LLP
Published May 6, 2013
DOJ to pursue enforcement Read More »
By Gary C. Messplay, J.D.
Published March 1, 2007
The Agency continues its revamp of cGMPs Read More »
By Shamik Pandit and Marcia Gartzke
Published August 22, 2005
A sponsor's guide to the audit process Read More »
By Ralph Tyree, Ph.D.
Published August 22, 2005
A contract API manufacturer explains how to build with cGMP in mind. Read More »
By Thomas Wilson, Magdalena R. Mejilano
Published August 22, 2005
An alternative strategy for long-term outsourcing of cGMP services. Read More »
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