GMP

We are offering a 1-day training course covering the essential “what you need to know” when it comes to GMP Part I Manufacturing Medicinal Products. Learn about the key requirements in each of the 9 chapters including the main inspection focus areas and how to avoid an audit finding.

This course applies to manufacturers that undertake the collection, processing, testing, storage, release for supply, and quality assurance of Human Blood and Blood Components, Human Tissues and Human Cellular Therapy Products.  The purpose of this workshop is to provide participants with an understanding of the Australian Code of GMP for human blood and blood components,...

This one-day Validation training workshop is designed to provide an overview of the current concepts and guidance documents for Validation as defined by the US FDA in 2011 and PIC/S Annex 15 Qualification and Validation. The aim of the course is to provide practical insights into how validation is carried out and avoid common and...