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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.