Two-Day Training<\/p>\n
This two-day advanced training is designed for professionals in the biopharmaceutical, pharmaceutical, and medical device industries who are involved in stability program development. The program will cover key regulatory requirements, best practices for study design, data analysis, and risk management. Participants will gain the skills to design robust stability programs that comply with global guidelines (ICH, FDA, EMA) while optimizing product shelf life and quality.\u00a0\u00a0<\/span><\/p>\n This training aligns with industry needs by ensuring compliance, reducing regulatory risks, and improving product stability strategies.<\/span><\/p>\n By the end of this training, participants will be able to:\u00a0\u00a0<\/span><\/p>\n Module 1<\/strong>: Introduction to Stability Studies in Biopharma <\/span>– Importance, objectives, and industry challenges.\u00a0\u00a0<\/span><\/p>\n Module 2<\/strong>: Regulatory Guidelines (ICH, FDA, EMA)<\/span>\u00a0– Key requirements for stability testing in biologics.\u00a0\u00a0<\/span><\/p>\n Module 3<\/strong>: Stability Study Design & Protocol Development<\/span>\u00a0– Selection of batches, storage conditions, and test intervals.\u00a0\u00a0<\/span><\/p>\n Module 4<\/strong>: Case Study: Stability Protocol Review<\/span>\u00a0– Hands-on evaluation of a real-world protocol.\u00a0\u00a0<\/span><\/p>\n Module 5<\/strong>: Stability Data Evaluation & Statistical Tools<\/span>\u00a0– Trend analysis, shelf-life estimation (ANOVA, regression).\u00a0\u00a0<\/span><\/p>\n Module 6<\/strong>: Handling OOS & Deviations in Stability Studies <\/span>– Root cause analysis and corrective actions.\u00a0\u00a0<\/span><\/p>\n Module 7<\/strong>: Risk-Based Stability Program Optimization<\/span>\u00a0– Identifying critical parameters and failure modes.\u00a0\u00a0<\/span><\/p>\n Module 8<\/strong>: Regulatory Submissions & Mock Audit Exercise<\/span>\u00a0– Preparing stability reports for inspections.\u00a0\u00a0<\/span><\/p>\nLearning Objectives<\/span><\/h2>\n
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