This one day course provides the delegate with understanding of the principles of and practical application of Quality Risk Management (QRM). The course is focused on ICH Q9 (QRM) requirements and its use in development, manufacturing, engineering, validation or other functions. It also covers its links to ICH Q8 (Pharmaceutical Development), Q10 (Quality Systems) and Q11 (Drug Substance Development) and ICH Q12 (Lifecycle)
The 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 will also cover the intent and outline content of the ICH's recent draft ICH Q8(R1) that was sent out for industry comment end 2021 and is due for final publication later in 2022. If this final version is published by the time of the course, the course will fully take this into account.
The 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 will also cover the intent and outline content of the ICH's recent draft ICH Q8(R1) that was sent out for industry comment end 2021 and is due for final publication later in 2022. If this final version is published by the time of the course, the course will fully take this into account.
