Event Detail
Drug Products Stability and Shelf-Life
August 20 - 21, 2009
- North York ON CANADA
International Pharmaceutical Academy
enquiry@ipacanada.com
Phone: 416-502-AAPS (2277)
Fax: 416-502-2278
A Two-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 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