Stabiity Testing in Pharmaceutical Development and Manufacturing
05 Jun 2014 - 06 Jun 2014 - Amsterdam, The Netherlands
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