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UKTraining

Stability Testing in Pharmaceutical Development and Manufacturing


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Who should attend?

The course is designed for people working in: * Analytical and Product Development * Analytical Chemistry * Stability Testing * Formulation Development * Regulatory Affairs * Pharmaceutical & Biopharmaceutical Production * Quality Control and Quality Assurance * Technical Operations

Details

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. 

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

Contact

Judith Callanan
info@pharma-training-courses.com

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