An up-to-date and well-established residential course designed to:
Provide delegates with a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals and related products.
Illustrate the essential steps in the development of stability testing protocols through practical examples.
Inform delegates about all aspects of stability testing, including criteria for product stability, challenges associated with specific product types (including biotechnology products, complex formulations and devices), application of statistical tools and new technology for stability assessment, and the application and limitations of stability test procedures.
Discuss UK and international regulatory aspects, including the guidelines for stability testing within the EU, Japan and the USA introduced through the ICH.
Enable delegates to discuss real challenges faced in day-to-day work through a blend of interactive workshops and informative presentations.
Provide delegates with opportunities for informal discussion and problem-solving sessions with the experts. Delegates are encouraged to bring problems to discuss at the workshop sessions.
Allow delegates to network with course tutors and other delegates from the field through an informal welcome reception and course dinners.
Provide reference material for use after the course through a full resource pack and CD-ROM with relevant reference documents.
Provide delegates with a detailed appraisal of the rationale and techniques associated with the stability testing of pharmaceuticals and related products.
Illustrate the essential steps in the development of stability testing protocols through practical examples.
Inform delegates about all aspects of stability testing, including criteria for product stability, challenges associated with specific product types (including biotechnology products, complex formulations and devices), application of statistical tools and new technology for stability assessment, and the application and limitations of stability test procedures.
Discuss UK and international regulatory aspects, including the guidelines for stability testing within the EU, Japan and the USA introduced through the ICH.
Enable delegates to discuss real challenges faced in day-to-day work through a blend of interactive workshops and informative presentations.
Provide delegates with opportunities for informal discussion and problem-solving sessions with the experts. Delegates are encouraged to bring problems to discuss at the workshop sessions.
Allow delegates to network with course tutors and other delegates from the field through an informal welcome reception and course dinners.
Provide reference material for use after the course through a full resource pack and CD-ROM with relevant reference documents.
