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  Events - June 2014

Stabiity Testing in Pharmaceutical Development and Manufacturing

05 Jun 2014 - 06 Jun 2014 - Amsterdam, The Netherlands

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This course has been updated to reflect the recent changes in the pharmaceutical stability testing world. The new course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly testing area. It will include opportunities for review of specific participant problems The course will cover: Recent regulatory changes affecting stability including * The implications of implementation of ICH Q7, Q8, Q9, Q10 and Q11 for stability testing * Changes to European GMP guidance with impact on stability testing including Annexe updates affecting product development, outsourcing and application of Quality Risk Management (QRM) * Product Quality Reviews and the interpretation of stability data. Recent scientific developments with implications for stability, with a particular focus on cost reduction, shortening of development timelines, and improvements on existing interpretation systems * ASAP - using short term high stress testing to get accurate predictions of shelf life with a high degree of confidence – Freethink Technologies’ ASAPprime® * Low level impurities and their impact on product stability * Manipulation of tablet internal pH to improve product stability

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