Method Validation and Verification in the Laboratory

Method Validation and Verification in the Laboratory

Method Validation and Verification in the Laboratory is a process by which it is established, through laboratory studies, that the performance characteristics of a method meet the requirements for its intended analytical applications. Method Validation typically evaluates the following analytical characteristics of a method: Accuracy, Precision, Specificity, Detection Limit, Quantitation Limit, Linearity, Range and Robustness.

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Method Validation and Verification in the Laboratory

 

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Course Dates:
    • June 2022

Method Validation and Verification in the Laboratory is a process by which it is established, through laboratory studies, that the performance characteristics of a method meet the requirements for its intended analytical applications. Method Validation typically evaluates the following analytical characteristics of a method: Accuracy, Precision, Specificity, Detection Limit, Quantitation Limit, Linearity, Range and Robustness. Depending upon the type of method and its application, not all the analytical characteristics indicated above will be required for validation.

The main objective of the validation is to demonstrate that the analytical method is suitable for its intended purpose, is accurate, specific and precise over the specified range that an analyte will be analyzed.

Method validation provides an assurance of reliability during normal use, and is sometime referred to as “the process for providing documented evidence that the method does what it is intended to do.”

 

Who Should Attend

All professionals working in the laboratory

Course Topics

· Introduction

· Methods

· FDA vs CE IVD in terms of validation/verification

· Validation/Verification in the following Sections:

  1. Chemistry and immunology
  2. ELISA
  3. Molecular Biology
  4. Rapid Test
  5. POCT
  6. Anatomic pathology
  7. Haematology and Coagulation

· Acceptance criteria for each step in each section

· How to create your Final Validation Report