Event Date/Time: Jan 26, 2010 | End Date/Time: Jan 27, 2010 |
Registration Date: Jan 26, 2010 | |
Early Registration Date: Dec 17, 2009 |
Description
- FDA, Health Canada, WHO and ICH Guidelines; Q1A, Q1C, Q1D, Q1E, Q1F, Q2A, Q2B, Q3A and Q3B
- ICH Climate Zones
- Types of Stability Studies - Stability Study Designs
- Developmental Stability Studies (i.e., Phase 1 to 3)
- Consistency Studies for drug submission
- Validation Studies
- Routine Stability Studies (Marketed products)
- Setting-up Stability Program Policies, Procedures, SOPs and Study Protocols
- Preparation of Stability Reports
- Consideration in Developing Stability Indicating Methods
- Designing Reduced Testing Program: Bracketing & Matrixing
- Rational for Study Duration and Shelf-life Determination
- Testing Intervals; Long Term and accelerated
- Study Stability Batch Selection, Sample Size, and Sample Management
- Stability Chambers: Mapping, Qualification and Monitoring
- Study Tracking
- Stability Testing and Evaluation
- Stability Trending, Failure Investigation; OOS, and OOT
- Review of Recent Stability Related 483s