Tag Archive: FDA

Case Processing Deficiencies

In our last posting we discussed problems in quality management systems found during audits and inspections.  In this posting we want to discuss problems seen during inspections regarding the processing of individual case safety reports (ICSRs). Health agencies, in particular the FDA and the EMA/member states, have detailed requirements on[…]

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Quality (QA QC QMS) Deficiencies

In May of this year I did a posting on the Quality Management Systems (QMS) that are obligatory for DS/PV departments based on FDA’s Quality Manual and the EMA’s Good PV Guidelines Module 1. Since then I have done many audits of drug safety and PV groups around the US[…]

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Generic Safety Labeling: FDA’s new regulation – Part 1

On November 8, 2013 FDA published an announcement in the Federal Register regarding new labeling requirements for generic drugs.  (See http://telerx.bz/3n) It was officially published November 13, 2013.  There will be a 60 day comment period and then, presumably, FDA will make the regulations final and they will take effect –[…]

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