The aim of this two day course is to provide guidance on
how QbD principles can be applied to analytical methods
and identify the opportunities, not only for new development
products, but also for drugs already marketed.
This course will deal among others with the following
questions:
->What are the opportunities of applying QbD and life
cycle approach to analytical methods?
->What is the current status of analytical QbD (USP,
FDA-EMA, FDA Draft Guidance Method Validation)?
->How can the Analytical Target Profile increase regulatory
flexibility?