LABORATORY METHOD VERIFICATION-VALIDATION TRAINING

Method validation and verification are important concepts used to ensure the reliability and accuracy of analytical methods. These processes are crucial in fields such as food, pharmaceuticals, environmental sciences, and biotechnology. Method validation refers to a series of experimental studies conducted to determine whether a method is suitable and reliable for a specific purpose, while verification is the process of confirming the applicability of a validated method in a particular laboratory.

What is Method Validation? Method validation is a process in which the performance of an analytical method is assessed before it is used for a specific purpose. Parameters such as accuracy, precision, repeatability, linearity, specificity, and robustness are examined during the validation process.

Parameters evaluated in method validation:

• Accuracy: The ability of the method to measure a known value accurately.
• Precision: The method's ability to detect the analyte at very low concentrations.
• Repeatability: The closeness of measurements obtained under the same conditions on the same sample.
• Linearity: The linear relationship between the concentration of the analyte and the signal obtained.
• Specificity: The ability to distinguish the analyte from other substances.
• Robustness: The sensitivity of the method to changes in conditions (e.g., temperature, pH).

What is Method Verification? Method verification is the process of confirming the applicability of a validated method in a specific laboratory. In this process, the parameters established in the validation study are repeated under the laboratory's own conditions. Verification demonstrates that the method can be properly applied by the laboratory personnel and that the results obtained are reliable.

Methods for Method Validation and Verification Various methods are used for method validation and verification. These methods may vary depending on the substance to be analyzed, the analytical technique used, and the laboratory's capabilities.

Commonly used methods:

• Standard Addition Method: Adding a known amount of standard substance to the analysis to evaluate accuracy and linearity.
• Internal Standard Method: Adding a known amount of internal standard to the analysis to evaluate precision and repeatability.
• Recovery Experiments: Determining the recovery percentage of an added substance to evaluate accuracy.
• Limit of Detection (LOD) and Limit of Quantification (LOQ): Determining the lowest concentration that the method can detect and quantify with certainty.

Method validation and verification are critical to ensuring the reliability of analytical results. These processes are an essential part of the quality assurance systems in laboratories. Properly conducted validation and verification studies ensure that the results obtained are scientifically acceptable.

Method validation refers to a process of experimental studies conducted to determine the suitability and reliability of an analytical method for a specific purpose. Simply put, it is a testing process to ensure that the method used gives accurate results.

Method verification, on the other hand, is the validation process that is conducted to ensure that a previously validated method can be applied by a different laboratory or user. This means confirming that the method shows the same performance under new conditions.

Why is Method Validation and Verification Important?

• Reliable Results: Validation of the method is essential for obtaining accurate and reliable results.
• Quality Assurance: Methods used must be accurate to ensure the quality of the product or service.
• Legal Compliance: In many industries, method validation is a legal requirement.
• Decision Making: Reliable results lead to better decision-making.

Scope of Method Validation and Verification Training These trainings typically cover the following topics:

• Basic Concepts: The difference between validation and verification, performance parameters (accuracy, precision, linearity, etc.), statistical methods.
• Validation Stages: Planning, experimental studies, data analysis, reporting.
• Verification Stages: Transfer studies, performance comparison, reporting.
• Validation and Verification Parameters: Calculating and evaluating parameters such as accuracy, precision, linearity, measurement limits, specificity, robustness.
• Statistical Methods: Statistical methods used for data analysis (t-tests, ANOVA, regression analysis, etc.).
• Quality Assurance Systems: Compliance with quality assurance systems like ISO/IEC 17025.
• Application Areas: Examples of applications in various sectors such as food, pharmaceuticals, environmental sciences, and biotechnology.

Benefits of Training:

• Knowledge and Skill Development: Participants acquire the necessary knowledge and skills in method validation and verification.
• Risk Reduction: Reduces the risk of errors by selecting and using correct methods.
• Increased Efficiency: Increases productivity in work processes by providing accurate and reliable results.
• High Quality Products and Services: Contributes to providing high-quality products and services.
• Legal Compliance: Helps meet legal requirements.

Who Should Attend the Training?

• Laboratory Personnel: Analytical chemists, quality control experts, laboratory managers.
• Production Personnel: Staff involved in analytical processes in production.
• Quality Assurance Specialists: Those responsible for improving quality systems.
• Regulatory Affairs Professionals: Those looking to ensure compliance with legal regulations.

In conclusion, method validation and verification training is crucial for the proper and reliable use of analytical methods. Through this training, participants will gain the knowledge and skills needed to improve product or service quality, reduce the risk of errors, and comply with legal requirements.

Participant Profile: GLP (Good Laboratory Practice) developers and improvers, Laboratory Personnel, Managers, and Owners who want to implement, develop, and manage laboratory systems, as well as human resources and personnel interested in a career in laboratory standards.

Exam: An exam may be conducted at the end of the training.

Instructor: The training will be conducted by International Lead Auditors and Training Experts. It will be announced before the training.

Training Date: Announced before the training.

Training Duration: 2 days.

Training Location: Online/In-house.

Certification: A certificate will be provided to participants at the end of the training.