– an update for the 21st Century
The course content will provide a comprehensive update on current trends which offer substantial potential savings in time and resources in a traditionally costly and complex testing area. Previous participants say that as a result of the course they have been able to significantly reduce testing in some areas, and identified deficiencies in other areas. 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
This course repeatedly receives “Excellent” reviews by attendees.