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Critical Elements of Stability Program and Stability Testing
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
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