| Description |
Course Objectives:
Stability is defined as the capacity of a drug substance or drug product to remain within established specifications to maintain its identity, strength, quality, and purity throughout the retest or expiration dating periods. Stability assessment of drug products and drug substances are mandated by regulatory agencies across the globe. In fact stability testing issues are responsible for a quarter of all audit findings by regulatory agencies. Stability testing problems also are regularly cited in warning letters and sometimes result in costly product recalls.
This one and half day course and workshop is designed to provide everything you need to know on how to design and implement a comprehensive and compliant stability program.
The workshop emphasizes practical issues such as:
- Development of stability protocols
- Use of bracketing in stability studies
The course provides ample opportunities for group discussions, case studies and exercises. It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ expectations.
A One and Half Day Comprehensive and Interactive Course with Workshop on:
- 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
- Stability Policies and Procedures, SOP, Protocols, and
- Stability Reports
- Stability Indicating methods
- Reduced Testing; Bracketing & Matrixing
- Study Duration
- Stability Study Designs
- Developmental Stability Studies (i.e., Phase 1 to 3)
- Routine Stability Studies (Marketed products)
- Validation Studies
- Consistency Studies for drug submission
- ICH Climate Zones
- Stability Batch Selection, Sample Size, and Sample Management
- Stability Chambers and Sample Storage
- Tracking
- Stability Testing and Evaluation
- Stability Testing Intervals; Long Term and accelerated
- Stability Study Assessments
- Shelf-life Determination
- Stability Trending, Failure Investigation; OOS, and OOT
- Review of Recent Stability Related 483s
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