New regulation 536/2014 EC
In 2016 the new regulation 536/2014 EC will become effective. It will replace the current Directive 2001/20 about clinical trials. The document can be downloaded on the official site of the…
Presentation on FMEA
Today I came across an interesting presentation about FMEA. [slideshare id=14967973&doc=qualityriskmanagementfmea-121031093113-phpapp02]
Comments on the QP template are published by EMA
In 2011, the EMA has published two draft documents for a template for the QP's declaration concerning GMP compliance of the API used as starting material and verification of its…
Online QP training course
Today I came across a nice advertisement about an online training course. It is from Inspired Pharma training. The training is perfect for everybody who wants to become a QP,…