Stability testing of pharmaceuticals
A three-day residential course organised by the Royal Pharmaceutical Society in partnership with the Academy of Pharmaceutical Sciences.
A well-established and up-to-date course designed to provide participants with a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals and related products, which will give participants the chance to: learn about the essential steps in the development of stability testing protocols through practical examples; discuss UK and international regulatory aspects, including the guidelines for stability testing within the EU, Japan and the US introduced through the international Conference on Harmonisation; hear about all aspects of stability testing, including criteria for product stability, challenges associated with specific product types, including biotechnology products, complex formulation and devices, application of statistical tools and new technology for stability assessment, and the application and limitations of stability test procedures; put questions to experts and discuss real problems encountered in day-to-day work in informal workshops and problem-solving sessions; network with colleagues through a full social programme.
New for 2013
The 2013 course will also incorporate QbD principles, science based stability processes (e.g. Stability risk assessment, lean stability) and tools such as Accelerated Stability Assessment Protocol.