PharmaTraining Services, London
2009-15-01
DAY 1 Stability testing in context - what we do and why - Preclinical
- Clinical trial
- Formulation development
- Product registration
- Post approval
History of stability testing - How we got to where we are
- Role of ICH
Overview of ICH guidance relevant to stability testing - Stability testing
- Impurities
- Specification
Detailed review of ICH stability testing documents ICH Q1A Analytical Method Selection and Development Defining and setting specifications - ICH Guidance Q6A - Preclinical
- Clinical trial
- Product registration
Analytical Method Validation - Key techniques
- Method Selection
- Outsourcing of stability testing
DAY 2 Matrixing and bracketing pitfalls and purpose - ICH guidance Q1D Quality systems issues - Safeguarding data quality
Shelf lives and expiration dating - interpreting and using data - Applying ICH Guidance Q1E
Out spec and out of trend data. Assessing outliers Photostability testing of new dosage forms ICH Q1B - History, purpose and implementation of guidance
Applications/case studies Case 1 syrup preformulation paper Case 2 tablet formulation selection Case 3 Definitive testing Case 4 Busulfan liquid Group discussion, problem solving and consultancy
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