The Chromatographic Society and Joint Pharmaceutical Analysis Group are pleased to announce another one-day meeting in the series: “The Chromatographic (Analytical) method life cycle: From cradle to grave (III).”
Like previous meetings, it will have a full and exciting topic and speakers program one that has also been purposefully designed to facilitate delegate and exhibitor access to a wide range of scientists, many of whom are leaders in their field.
The meeting seeks to provide a clear insight into successful strategies in critical areas including the new ICHQ14 and ICH Q2 guideline updates, and other guidelines/chapter, such as the BP and JP chapters and upcoming USP<1220>, <1221> and <1225> chapters). It will cover 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. It will focus on analytical life-cycle management in the Pharmaceutical industry and the latest regulatory expectations, including AQbD and permitted chromatographic method changes according to main Pharmacopoeias.
The topics will also emphasise the 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, and Performance Monitoring, and how they are integrated into a 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. Where the aim is over time, that the proposed strategy should streamline analytical development, resulting in well-understood analytical methods, and simplify lifecycle management.
There will be several cases studies on how Pharma companies hope to holistically implement these advanced method development and lifecycle concepts in the context of a patient-centred approach and a risk-based control strategies. Including aligning and strengthening the link between the quality attributes of a product and an analytical procedure, and minimising the risks of future changes and impact on the overall product control strategy. The 2 day meeting will also cover predictive modelling and digital tools and how Industry needs to further strengthen the mindset and available skills in statistics.
These presentations will be delivered by highly regarded and experience international speakers from industry, regulators and the chromatography industry who will share their knowledge and experience in applying and implementing the principles of AQbD. We believe the calibre of the speakers, combined with a fully integrated exhibition and vendor presentation programme, will deliver a highly interesting and well attended event. Ultimately the meeting will provide attendees with a unique means of sharing real experiences with other professionals and will provide excellent networking opportunities. ChromSoc student bursaries are available for this event.
The meeting is designed to be a relatively low cost meeting to encourage attendance of delegates from life sciences. ChromSoc student bursaries are available for this event.
If you would like to discuss further, exhibit or present at this event please forward all requests to Adrian Clarke (adrian.clarke@novartis.com).
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