Institute of Validation Technology (IVT)

Start off the year with GXP, featuring some of your favorite authors like Ron Snee, Ph.D. who presents his paper “Root Cause Analysis – A Systematic Approach” which illustrates pharmaceutical and biotech case studies to dig deep into frequently occurring problems. Also, Tim Sandle Ph.D. provides a timely paper on EU GMP Annex 1, on Sterile Products Manufacture, that you won’t want to miss. Other topics featured are on deviation management and in-process bioburden testing.  

DOWNLOAD VOL. 22, ISSUE 1

GXP
Jan 23 2018 - 8:14 am
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...
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JVT
Jan 23 2018 - 9:10 am
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.
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Blog
Jan 23 2018 - 10:39 am
Quality risk management is no longer limited to quality operations, but has become a responsibility of employees throughout the organization.
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GXP
Jan 23 2018 - 6:26 am
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.
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