Description :Using the QbD approach for development and validation will result in more robust analytical methods. Advantages are easier method transfer, longer revalidation cycles and fewer or no methods specific Out-of-Specification situations when used in routine. In addition, FDA, USP and international agencies promote the QbD approach because it is expected that such performance based routine methods can be changed within the analytical target profile (ATP) without regulatory resubmission and approval. Moreover, the new FDA Method Validation Guide suggests using QbD elements for development and validation. Because there is no or little experience with the QbD approach for analytical methods, the industry has many questions.For easy implementation, attendees will receive:Master plan - Template and examples: Development and Validation of Analytical Methods through QbDSOP - Development and Validation of Analytical Methods through Quality by DesignChecklist - Validation of Analytical Methods according  to the FDA Guidance 2015Areas Covered in the Session :General principles and key benefits of QbDRegulatory background and trends: FDA, ICH Q8/9/10Reasons for changing the way we validate methodsCurrent applications of QbD in the pharmaceutical industryThe Application of QbD for analytical methodsComparison of the QbD process with ICH Q2 and USP <1225>Benefits for method transfer and routine useUsing the lifecycle approach for method design, development and validationDeveloping specifications and, the analytical target profileDocumenting input variables for risk assessment in fishbone diagramsUsing the risk assessment prioritization matrix to select the test parametersTraditional vs. the QbD process for method parameter optimizationThe method validation and qualification studiesUsing the method in the routine: on-going performance control, review and change controlContinuous monitoring and improvementsDocumentation requirementsDefining the Analytical Target Profile (ATP) and design spaceCase studiesWho Will Benefit:A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of drug substances (APIs) and Contract laboratories, Contract manufacturing organizations, Clinical research organizations. The teams that will benefit the most are:QA Managers and PersonnelAnalysts and Lab ManagersRegulatory AffairsTraining DepartmentsMethod Development DepartmentsDocumentation DepartmentsConsultants