AQbD is the application of the Quality by Design methodology to develop robust analytical methods.
For some time now it has been applied in some companies, but international regulations are aligning to normalize its full application: ICH Q14, ICH Q2 R1 (revision), USP <1220>, MHRA: Technical Review AQbD Project, are some of them.
In this course, the AQbD methodology is established in the analytical field.
Two workshops will be carried out to apply the risk analysis to define the method critical variables. Examples of DoE to optimize and to make the method more robust will be delivered.
The DoE workshop will be held with Minitab and attendees may use their laptop with a trial license for a hands-on experience during the workshop.