Location

Productivity and Quality Institute - Alexandria

Objectives

• The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose.The course introduces the main concepts and mathematical apparatus of validation, covers the most important method performance parameters and ways of estimating them.

Outcomes

The attendance that has successfully passed the course is able to• Perform complete method validation protocols;• Decide what data are needed for evaluating the different method performance parameters, understand the meaning of the available data and decide whether the available data are sufficient;• Select the approach and design the experiments for obtaining suitable data;• Quantify the relevant performance parameters using the available data and assess whether the obtained values are realistic;• Assess the fitness of the method for the intended purpose based on the values of the evaluated performance parameters;• Reporting the validation results;• Knowing the cases of revalidation;• Decide which situation can use validation, verification or method transfer according to USP requirements.

Course Contents

A- Data Analysis:1- Statsitics2- Data location3- Data Dispersion4- F test5- ANOVA5- T Test6- Regression7- Error8- OutlierB- Validation PlanC- Validation Process:1-Specificity2- Accuracy3- Precision4- Linearity5- Limit of detection (LOD)6- Limit of Quantization (LOQ)7- Range8- RobustnessD- Validation ReportingE- VerificationF- Method transferG- USP Recommendation