•Comprehensive 5-day technical program
•Practical training in method validation and measurement uncertainty
•Hands-on exercises with real data and case studies
•Focus on international standards and regulatory compliance
•Statistical techniques for assessing method performance
•Emphasis on reporting, documentation, and quality assurance

By the end of this course, participants will be able to :

•Understand the principles and importance of method validation
•Apply international standards for validation (e.g., ISO 17025, ICH, USP)
•Evaluate accuracy, precision, linearity, sensitivity, and specificity of methods
•Quantify measurement uncertainty and understand its impact on results
•Use statistical tools for data analysis and validation
•Implement corrective actions to ensure measurement reliability
•Prepare validation reports in compliance with regulatory requirements

This course is suitable for:

•Laboratory Managers and Supervisors
•Quality Assurance and Quality Control Professionals
•Analytical Chemists and Technicians
•Compliance and Regulatory Professionals
•R&D Scientists
•Professionals involved in method development, validation, and measurement

Day 1: Introduction to Method Validation

•Principles and objectives of method validation
•Regulatory and standard requirements
•Key parameters: accuracy, precision, specificity, sensitivity
•Validation planning and documentation
•Case studies and examples

Day 2: Validation Parameters & Experimental Design

•Accuracy, precision, linearity, range, limit of detection/quantification
•Robustness and ruggedness testing
•Designing experiments for method validation
•Data collection and analysis
•Hands-on exercises in experimental design

Day 3: Measurement Uncertainty Concepts

•Understanding measurement uncertainty
•Sources of uncertainty in analytical measurements
•Methods for estimating uncertainty
•Practical exercises in uncertainty calculation
•Interpretation and reporting of uncertainty

Day 4: Statistical Tools for Validation

•Statistical techniques for method evaluation
•ANOVA, regression, and control charts
•Repeatability and reproducibility analysis
•Software tools and practical applications
•Exercises using real datasets

Day 5: Reporting & Best Practices

•Preparing method validation reports
•Documentation and compliance with ISO/ICH standards
•Quality assurance and continuous improvement
•Lessons learned from case studies
•Group exercises, review, and key takeaways

CDGA attendance certificate will be issued to all attendees completing a minimum of 80% of the total course duration.