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Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines
Jul 27, 2017 - 08:30 AM - Jul 28, 04:30 PM
Link to Website
Hyatt Place Miami Airport-East 3549 NW 42nd Ave, Miami, FL 33142, USA,
Phone: 1 929 900 1853
Day 1 Schedule
Overview of ICH Methodology
Introduction to the simple regression model
Interpreting the slope and intercept in validation procedures
Residual analysis and error detection
Stability and Potency issues
Outlier strategies using the linear model in calibration methods
Imputation techniques for missing data
Outlier strategies for non normal or ranked data
Consequences of outlier elimination/substitution
Sample size and analysis issues
Confidence and tolerance bounds on risk models
Parametric and non parametric (non normal data) procedures
Exact computational techniques
Day 2 Schedule
Discussion of risk management in general
Traditional risk management strategies in clinical settings
Predictive models in risk assessment
Discussion of the Design Space
Risk Management in pre-analytical phase of laboratory testing
Introduction to validation of models in hazard assessment and risk management
Demonstration of laboratory Validation procedures
Bivariate models and confusion matrices and derived statistics
Statistical process laboratory control and capability
Normal and non normal data procedures
Evolutionary Operations Process
Confidence and tolerance bounds on limits of risk
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