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February 02, 2014
Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how human error can be mitigated in pharmaceutical manufacturing.
Non-compliance issues show that users find dealing with computer systems challenging.
January 30, 2014
EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.
January 24, 2014
FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location
January 22, 2014
Online portal accepts nominations for FDA advisory committee membership.
January 09, 2014
FDA releases guidance on developing drugs for the treatment of community-acquired bacterial pneumonia.
January 08, 2014
EMA has launched a new version of the EudraGMDP database, which includes the publication of statements of non-compliance with good manufacturing practice.
January 02, 2014
Different approaches for qualification of personnel for visual inspection of residues on equipment surfaces are reviewed.
Kurt Lumden, Director, Client services at PAREXEL's Perceptive Informatics, discusses the management of investigational product temperature excursions.
This article takes a statistical look at the calibration requirements for a UV spectrometer.