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globally that are responsible for defining Good Manufacturing Practice requirements, as well as updated and draft guidance documents from PIC/S, ICH and FDA.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