Pharma Training, Window Conference Venue, London UK
16 & 17 May 2011
Course Programme
DAY 1 Stability testing in the new world of QbD - Stability testing and the Lifecycle approach to product development
- Formulation development
- Manufacturing
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
- Specifications
LUNCH
Detailed review of ICH stability testing documents ICH Q1A
Defining and setting specifications – ICH Guidance Q6A - Preclinical
- Clinical trial
- Product registration
ASAP – a new approach to stability testing the drug product
Question and Answer session
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.
LUNCH
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
Workshop and examples based on delegate’s interests
Group discussion, problem solving and consultancy
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