Conference Description:

This program will teach you to set specifications for drug substance and drug product,including use of release test data, long term stability, accelerated stability and special stability studies. The webinar will also cover changing specifications during lifecycle management.

Areas Covered in the Session :

>. Setting initial specifications
>. How to use available data and justify specifications
>. ICH specific recommendations will be discussed
>. Information required to br submitted during the lifecycle
>. Updating the specifications during developing and commercial phases

Who Should Attend:

>. Manufacturing Departments
>. Supply Chain Departments
>. Technical Operations Departments
>. Quality Control Departments
>. Quality Assurance Departments
>. Regulatory Affairs Departments