Welcome and Keynote Session II

Per FDA guidance on analytical methods, new information and risk assessments may warrant the
development and validation of a new or alternative analytical method over the lifecycle of a product. New
technologies may allow for greater understanding and/or confidence when ensuring product quality. Per ICH
Q10, innovation, continual improvement, the outputs of process performance and product quality monitoring
and CAPA drive change. In order to evaluate, approve and implement these changes properly, a company
should have an effective change management system. ICH Q12 provides guidance on technical and
regulatory considerations for lifecycle management including the concept of “established conditions” and
the impact of that determination on method changes (including a CE example). This presentation will build
from that background and further explore how Quality Systems and Quality Culture can increase the overall
agility of post approval method changes.