VALIDATION AND VERIFICATION OF QUANTITATIVE AND QUALITATIVE TEST METHODS

Course Objectives

• Understand the importance of Test Methods Verification and Validation.
• Prepare the Verification and Validation Master Plan.
• Identify the Method validation and validation parameters.
• Determine the limit of detection (LOD) and limit of quantitation (LOQ).
• Understand the Measurement Uncertainty
• Determine the level of acceptance of the test method

Target Audience

Management Representative, Management System Committee, Engineers, Chemist, and Internal Auditor.

Course Modules

MODULE 1 – INTRODUCTION
MODULE 2 – METHOD VALIDATION AND VALIDATION PARAMETERS
MODULE 3 – LIMIT OF DETECTION AND LIMIT OF QUANTITATION
MODULE 4 – VALIDATION PARAMETERS
MODULE 5 – DAY 1 WRAP-UP
MODULE 6 – DAY 1 REVIEW
MODULE 7 – SOFTWARE AND COMPUTER SYSTEM VALIDATION AND QUALIFICATION
MODULE 8 – VALIDATION OF ANALYTICAL METHOD
MODULE 9 – HANDLING OUT-OF SPECIFICATION SITUATIONS
MODULE 10 – WRAP-UP