PharmaTraining Ltd, London UK
14 & 15 May 2013
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
Who Should Attend?The course is designed for people working in:
- Analytical Development
- Analytical Chemistry
- Stability Testing
- Formulation Development
- Regulatory Affairs
- Pharmaceutical & Biopharmaceutical Production
- Product Development
- Technical Operations