This highly interactive eLearning course is aligned to the latest science and risk based principles and regulatory guidances in the EU and US. It will go into detail on the steps involved in carrying out a risk exercise, from the initiation stage to completion and review. It also covers the intent and outline content of the ICH's recent draft ICH Q8(R1) that was sent out for industry comment at the end 2021 and is due for final publication later in Q3 2022.
If you wish to try before you buy, book free trial version.
This course is suitable for people in development, manufacturing, engineering or validation who may have no, or limited quality risk management experience or for those with experience but who wish to be updated with the latest application, particularly regarding science and risk based principles.
By the end of the course you will be able to: