FDA and other regulators routinely request to see lists of deviations, non-conformances, CAPAs, complaints, and out of specification investigations during inspections. For nearly 20 years, failure in these systems has been in the top 5 of all observations issued. So what are we doing wrong?
Dr Willis Thomas of Akorn Pharmaceuticals reviews his presentation entitled "Educate for Data Governance," originally presented live at two IVT Network global conference in 2015 and in 2016. D
The purpose of the current Annex, and its continuation as a new, finalized version expected later in 2018, is to emphasize that the manufacture of sterile products is subject to special requirements.
Corrective and Preventive Action are an integral part of the DMAIC framework. The concepts and methods involved are illustrated with pharmaceutical and biotech case studies and examples.
The validation of the Growth Direct™ system is described for the automated incubation and enumeration of microbial colonies derived from in-process bioburden testing at a biologic facility using TSA media plates.