| Description |
- 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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| Additional Information |
This one and half day course is valuable for associates, managers, as well as new stability team members in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Quality Assurance
- Quality Control
- R&D
- Analytical Laboratory
- Contract Laboratory
- Product Submission
- Validation
- Documentation and Technical Writing
- Regulatory Affairs
- Project Management
- Product Development
- Training
- Consultant
- Stability
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