OR WAIT null SECS
February 02, 2010
Leading experts share insight on the current and future direction of process analytical technology. This article contains bonus online material.
January 02, 2010
Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing.
December 01, 2009
The quality assurance environment is forcing pharmaceutical companies to face new challenges. In light of this, the authors conducted a study of professionals from some of the world's top pharmaceutical companies to identify key QA concerns.
October 02, 2009
Is the square root of (N) + 1 a statistically valid scheme?
August 02, 2009
The author of an ambitious book about quality control falls short of reaching his goals.
June 02, 2009
A book guides readers through the regulatory requirements for computerized quality systems.
August 02, 2008
Myth versus Reality: What does Q10 implementation really mean for my company?
July 02, 2008
A new book explains process analytical technology, drug stability, and quality.
May 01, 2008
Process designs and control strategies can be improved by adopting a risk-based approach to product quality. The author describes how this approach can be applied to spray-drying operations.
January 02, 2008
QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.