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FDA's Risk-Based Method to Prioritize CGMP Inspections for FDA Regulated Industries |
| A Risk Ranking Model and guide for prioritizing preparations |
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As per the statement of Federal Food, Drug, and Cosmetic Act, FDA is supposed to conduct regular inspections at the manufacturing establishments of FDA Regulated companies. Considering that the number of registered FDA establishments have been increasing rapidly in the last 25 years, as part of the Agency's CGMPs for the 21st Century Initiative, the FDA has a risk-based inspection model for prioritizing FDA manufacturing establishments for routine inspection. The model is based on a risk-ranking and filtering method that is well-recognized, objective, and rigorously systematic. Organizations from the FDA regulated industries need to prioritize the action items while preparing for the FDA CGMP inspections, and hence need to understand in details the risk ranking model for comparing and prioritizing risks.
This webinar will cover:
- Risk estimation, filtering and ranking
- Desirable attributes of an idealized risk categorization system for risk ranking
- Hazard identification and conceptual modeling
- Development of risk ranking model
- Implementation of the model and risk estimation
- Best of breed processes and tools used in the industry for risk estimation, filtering and ranking
