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ICTD International Centre for Training and Development

Advanced GLP: Uncertainty Measurement, Data Validation, Method Validation & Statistical Process Control (SPC) in Analytical Laboratory According to ISO 170251

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Description

Good laboratory practice means different things to different people. This course covers the advance topics in Good Laboratory Practice (GLP). All practices that ensure that laboratory testing is planned, performed, monitored, recorded and reported in an organized and controlled manner, will be discussed in general and the Uncertainty Measurement in particular.

The course provides training of the Good Laboratory (GLP) for personnel of laboratories who wish to produce test results that are fit for the purpose and which would stand up to the scrutiny. The primary objective of the GLP is to ensure the generation of high quality data. Statistical tools play an important role in GLP to calculate the Uncertainty Measurement. This course will focus on the latest techniques and standards developed to measure the uncertainty of the data.

This course will use the Statistical Process Control (SPC) module as a tool to validate the uncertainty measurement. It covers control charts and their applicability to uncertainty before covering a step-by-step process of calculating uncertainty for typical application. Methods of reporting uncertainty, the uncertainty budget and applicable standards and guidelines for expressing measurement uncertainty are covered in some detail. Successful completion of this course will enable participants to understand, evaluate and express measurement uncertainty.

Course Objectives

Upon successful completion of this course, the delegates will be able to:

  • Apply an in-depth knowledge in the Good Laboratory (GLP) in accordance with the international rules and standards
  • Practice uncertainty measurement, data validation, method validation and statistical process control in compliance with the latest revision of ISO 17025 standard
  • Implement the Good Laboratory Practice (GLP) and gain advanced knowledge in modern laboratories GLP system
  • Distinguish the various GLP standards and regulations that set out the requirements for technical competence and proper management of analytical laboratories
  • Describe the GLP requirements related to organization, personnel, facilities, equipment, operations, testing, control, protocols, records and reports
  • Recognize the scope, field of application, components & sources of uncertainty and carry out analytical measurement & experimental studies of method performance
  • Identify uncertainty sources and employ the process of quantifying uncertainty
  • Carryout the process of calculating the combined uncertainty and be able to review the procedure on reporting uncertainty
  • Apply method validation techniques in accordance with ISO17025
  • Describe what is good laboratory practice and its importance in modern laboratories and in technology transfer
  • Discuss the GLP requirements related to organization, personnel, facilities, equipment, operations, testing, control, protocols, and records and reports
  • Identify uncertainty sources and employ the process of quantifying uncertainty

Course Outline

Day 1

GLP: Quality Assurance, Importance

  • Quality Assurance & Quality Control
  • Importance of ISO17025
  • GLP (Importance in Modern Laboratories and Technology Transfer)

Day 2

GLP: Cost, Standards, and Requirements

  • Cost of GLP Non-Compliance
  • GLP Standard
  • Requirements of GLP Compliance

Day 3

GLP: Issues, and Requirements

  • GLP Compliance Issues
  • GLP Requirements
  • Organization
  • Personnel
  • Facilities
  • Equipment
  • Operation
  • Testing
  • Control
  • Protocols
  • Records and Reports
  • GLP Scope
  • Field of Application
  • Components and Sources of Uncertainty
  • Conduct Analytical Measurement
  • Experimental Studies of Method Performance

Day 4

GLP: Process, Measurement, and Uncertainty

  • Process of Measurement Uncertainty Estimation
  • Uncertainty Sources
  • Process of Quantifying Uncertainty

Day 5

GLP: Calculating, Procedure, and Statistical

  • Calculating the Combined Uncertainty
  • Procedure on Reporting Uncertainty
  • Statistical Process Control – Application

Who should attend

This course provides an overview of all significant aspects and consideration of GLP in accordance with the international standards for those involved in laboratory management. This includes laboratory managers, superintendent, supervisors, scientists, doctors, physicians, chemists, researches, analysts, officers, coordinators and other technical staff. R&D and government statutory employees will benefit from international standards and regulation part of the course. Further, this course is important for QC/QC employees and Third Party Inspection.

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