This one and a half day training course is designed to provide further understanding of how to apply Quality by Design and lifecycle management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach.
Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. Experience with method development, validation and transfer of HPLC methods is advantageous.
Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. Experience with method development, validation and transfer of HPLC methods is advantageous.
