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Critical areas including: - the new ICH Q14 and ICH Q2 guideline updates, and other guidelines/chapters such as the BP / JP chapters and the upcoming USP chapters <1220>, <1221> and <1225>. - covering all stages, from method development and robustness using a range of separation techniques (LC, SFC, GC, CE), qualification and validation, transfer and continuous performance monitoring. - analytical life-cycle management in the pharmaceutical industry and the latest regulatory expectations including AQbD and permitted chromatographic method changes according to the main pharmacopoeias. - holistic Analytical Quality by Design (AQbD) framework for analytical procedure development and lifecycle management - key elements of the enhanced approach described in ICH Q14 including Analytical Target Profile (ATP), Knowledge Management, Analytical Risk Assessment, Performance Monitoring, and how these are integrated into the holistic Analytical Quality by Design (AQbD) framework for analytical procedure development and lifecycle management. - how to leverage a risk-based approach and balance between the benefits of post-approval flexibility and the resource investments required for implementation of the additional elements. - proposed strategies to streamline analytical development, resulting in well-understood analytical methods, and simplify lifecycle management. - environmental sustainability considerations and opportunities - industry case studies on how to implement these advanced method development and lifecycle concepts in the context of a patient-centred approach and risk-based control strategies. - aligning and strengthening the link between the quality attributes of a product and an analytical procedure - minimising the risks of future changes and impact on the overall product control strategy. - predictive modelling & digital tools and how industry needs to further strengthen the mindset and available skills in statistics.