Validation

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 of great importance, especially in fields such as food, medicine, environment and biotechnology. While method validation refers to a series of experimental studies conducted to determine the suitability and reliability of a method for a specific purpose, verification is the process of verifying the applicability of the method developed as a result of validation studies in a specific laboratory.

What is Method Validation?

Method validation is a process in which the performance of an analytical method is evaluated before it is used for a specific purpose. In this process, parameters such as accuracy, sensitivity, repeatability, linearity, specificity and durability of the method are examined.

Parameters evaluated in method validation:

• Truth: The ability of the method to accurately measure a known value.
• Sensibility: The ability of the method to detect very low concentrations of the analyte.
• Repeatability: The closeness of measurements made on the same sample under the same conditions.
• Linearity: Linear relationship between concentration and signal obtained at different concentrations of the analyte.
• Specificity: The ability of the analyte to be determined by separating it from other substances.
• Durability: Sensitivity of the method to changes in different conditions (e.g. temperature, pH).

What is Method Verification?

Method verification is the process of verifying the applicability of a validated method in a specific laboratory. In this process, the parameters determined in the validation study are repeated under the laboratory's own conditions. Verification indicates that the method can be applied correctly by laboratory personnel and that the results obtained are reliable.

Method Validation and Verification Methods

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 facilities of the laboratory.

Commonly used methods:

• Standard adding method: Accuracy and linearity evaluation by adding a known amount of standard substance to the analysis.
• Internal standard method: Assessment of precision and reproducibility by adding a known amount of internal standard to the analysis.
• Recovery experiments: Accuracy assessment by determining percent recovery of spiked material.
• Limit of detection (LOD) and limit of quantification (LOQ) determination: Determining the lowest concentration that the method can detect and the lowest concentration that it can detect precisely.

Method validation and verification are critical to ensuring the reliability of analytical results. These processes are an important part of laboratories' quality assurance systems. Validation and verification studies performed accurately and meticulously ensure that the results obtained are scientifically acceptable.

Method validationis a series of experimental studies performed to determine the suitability and reliability of an analytical method for a particular purpose. Simply put, it is a testing process to ensure that the method used produces accurate results.

Method verification It is a validation study carried out so that a previously validated method can be applied by a different laboratory or a different user. This means confirmation that the method performs the same under new conditions.

Why is Method Validation and Verification Important?

• Reliable results: To obtain accurate and reliable results, verification of the method used is essential.
• Quality assurance: The methods used to ensure product or service quality must be correct.
• Legal compliance: In many industries, validation of methods used is a legal requirement.
• Decision making: Accurate and reliable results enable better decisions.

Scope of Method Validation and Verification Training

The following topics are generally covered in these trainings:

• Basic concepts: 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: Calculation and evaluation of parameters such as accuracy, precision, linearity, measurement limit, specificity, robustness.
• Statistical methods: Statistical methods used for data analysis (t-test, ANOVA, regression analysis, etc.).
• Quality assurance systems: Compliance with quality assurance systems such as ISO/IEC 17025.
• Application areas: Application examples in different sectors such as food, pharmaceuticals, environment and biotechnology.

Benefits of Education

• Knowledge and skill development: Participants gain the necessary knowledge and skills regarding method validation and verification.
• Reducing the risk of errors: It reduces the risk of error by choosing and using the right methods.
• Productivity increase: It provides increased efficiency in business processes thanks to accurate and reliable results.
• Quality products and service: It contributes to the provision of quality products and services.
• Legal compliance: It helps to fulfill legal requirements.

Who Should Participate in Training?

• Laboratory staff: Analytical chemists, quality control specialists, laboratory managers.
• Production workers: Personnel who analyze production processes.
• Quality assurance experts: Those responsible for the development of quality systems.
• Those dealing with regulation: Those who want to comply with legal regulations.

In summary, Method validation and verification training is very important for the correct and reliable use of analytical methods. Thanks to this training, participants gain knowledge and skills to increase product or service quality, reduce the risk of errors and fulfill legal requirements.

Participant Profile: Those who want to develop and improve GLP Good Laboratory Practices, Laboratory Personnel, managers, owners, all human resources related to the subject who want to improve their careers.

Exam: Exam can be taken at the end of the training.

Trainer: Provided by our International Chief Auditor and Training Experts. Announced Before Training.

Training Date: Announced Before Training.

Training Duration: 2 days.

Training Location: Online/In-house

Certificate: At the end of the training, a certificate is given to those who attended the training.