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GMP Refresher Training


This 40 minute self-paced learning course provides important GMP refresher Training required for all individuals involved in the manufacture and supply of medicinal products.  It provides a reminder of the different regulatory organisations globally that are responsible for defining Good Manufacturing Practice requirements, as well as updated and draft guidance documents from PIC/S, ICH and FDA.  It also provides detail on the significant changes to Annex 1 implemented in August 2023.  It highlights the most frequent inspection findings against cGMP from both the FDA and MHRA, as well as a reminder of the Golden Rules of GMP.


This course is delivered in sections that will cover:

  • An overview of the regulatory organisations responsible for defining Good Manufacturing Practice requirements
  • Key Regulatory Changes in the EU-Annex 1 for the manufacture of Sterile Medicinal products
  • New guidance from PIC/S
  • New ICH draft documents
  • New US FDA documents
  • Regulatory inspection findings
  • The Golden Rules of GMP
  • A quiz to check understanding