Stability Testing in Pharmaceutical Development and Manufacturing

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

£1180.00

10% discount if booked and paid by 10 April 2014