Stability Testing in Pharmaceutical Development and Manufacturing

6 June 2019 09:00 - 7 June 2019 17:00, London, United Kingdom

The course will cover:
The impact of the lifecycle approach on product development:
  • 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, statistics, 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 - 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
DoubleTree Hilton Hotel

DoubleTree Hilton Hotel, 60 Pentonville Road, Islington, London, N1 9LA, United Kingdom

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