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Weblog

Happy New Year!

  • Post author:admin
  • Post published:January 1, 2015
  • Post category:Weblog

Continue ReadingHappy New Year!

New regulation 536/2014 EC

  • Post author:admin
  • Post published:November 5, 2014
  • Post category:Weblog

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…

Continue ReadingNew regulation 536/2014 EC

Presentation on FMEA

  • Post author:admin
  • Post published:September 26, 2014
  • Post category:Weblog

Today I came across an interesting presentation about FMEA. [slideshare id=14967973&doc=qualityriskmanagementfmea-121031093113-phpapp02]

Continue ReadingPresentation on FMEA

Comments on the QP template are published by EMA

  • Post author:admin
  • Post published:September 24, 2014
  • Post category:QP/Weblog

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…

Continue ReadingComments on the QP template are published by EMA

Online QP training course

  • Post author:admin
  • Post published:September 23, 2014
  • Post category:QP/Weblog

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,…

Continue ReadingOnline QP training course
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