Uncertainty of Measurement and Method Validation in Accordance with ISO 17025
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Uncertainty of Measurement and Method Validation in Accordance with ISO 17025 Course
Introduction:
To each individual, good laboratory practice will mean something different. The advanced themes of Good Laboratory Practice (GLP) are covered in this course. We'll talk about the Uncertainty Measurement (GUM) in particular as well as all the procedures that guarantee laboratory testing is struActured, regulated, planned, carried out, monitored, recorded, and reported.
Course Objectives:
Upon the successful completion of this course, participants will be able to:-
- Acquire an up-to-date knowledge on the quality assurance in laboratories and the importance of the ISO 17025 system
- Describe Good Laboratory Practice (GLP) and its importance in modern laboratories and in technology transfer
- Determine the cost of GLP non-compliance
- Gain knowledge on the various GLP standards and regulations that set out the requirements for technical competence and proper management of analytical laboratories
- Identify the common requirements of GLP compliance as per OECD, the USA, Canada, Europe, and Japan
- Explain the differences between the USA and OECD regulations and identify which system is suitable for your laboratory
- Discuss the critical GLP compliance issues
- Describe the GLP requirements related to organization, personnel, facilities, equipment, operations, testing, control, protocols, records and reports
- Recognize the scope, the field of application, components & sources of uncertainty and carry out analytical measurement & experimental studies of method performance
- Review & improve the process of measurement uncertainty estimation and be able to analyze the specification of the measurand
- Identify uncertainty sources and employ the process of quantifying uncertainty
- Carry-out the process of calculating the combined uncertainty and be able to review the procedure on reporting uncertainty
- Explain Statistical Process Control (SPC) and identify its applications
- Apply method validation techniques in accordance with ISO17025
Who Should Attend?
This course is aimed at all staff of Laboratories. This includes laboratory managers, superintendents, supervisors, scientists, doctors, physicians, chemists, analysts, officers, coordinators, and technicians. R&D and government statutory employees are encouraged to attend this outstanding course. Further, this course is very important for QA/QC employees and Third-Party Inspection and certification companies.
Course Outlines:
GLP: Quality Assurance, Importance
- Quality Assurance & Quality Control
- Importance of ISO17025
- GLP (Importance in Modern Laboratories and Technology Transfer)
GLP: Cost, Standards, and Requirements
- Cost of GLP Non-Compliance
- GLP Standard
- Requirements of GLP Compliance
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
GLP: Process, Measurement, and Uncertainty
- Process of Measurement Uncertainty Estimation
- Uncertainty Sources
- Process of Quantifying Uncertainty
GLP: Calculating, Procedure, and Statistical
- Calculating the Combined Uncertainty
- Procedure on Reporting Uncertainty
- Statistical Process Control – Application