Method Validation方法確認(ppt 61頁)

Method Validation - Objectives方法確認 – 目標
By the end of this session you will be able to通過學習你將能夠:
Evaluate a new method with respect to what type of validation data are required獲取相關確認數據，對新方法進行評估
Assess validation data to determine specific requirements that must be met for the validation to be verified and accepted評價確認數據，以確定方法確認應滿足的特定要求已經驗證並可接受
Presentation Outline報告講述要點
Definitions and ISO 17025 requirements相關定義及ISO 17025 要求
Validation process方法確認過程
Examples of validation procedures方法確認舉例
Parameters to be calculated參數計算
LOD, LOQ, precision, accuracy, uncertainty檢出限定量限, 精密度, 準確度, 不確定度
QA verification of data數據驗證的質量保證
What is a Method何謂方法?
An analytical method is to be regarded as the set of written instructions completely describing the procedure to be adopted by the analyst in order to obtain the required analytical result.分析方法是一套書麵說明,完整描述分析人員為獲得所需要的分析結果所采用程序。1

1Wilson, A.L. “The Performance Characteristics of Analytical Methods-I” (1970) Talanta 17, 21-29

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