Advanced GLP: Uncertainty Measurement, Data Validation, Method Validation and Statistical Process Control (SPC) in Analytical Laboratory According to ISO 17025
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Advanced GLP: Uncertainty Measurement, Data Validation, Method Validation and Statistical Process Control (SPC) in Analytical Laboratory According to ISO 17025 Course
Introduction:
Course Objectives:
Upon the successful completion of this course, participants will be able to:
- Understand the quality assurance in the laboratory and the importance of ISO 17025 system
- Describe what is the Good Laboratory Practice (GLP) and its importance in modern laboratories and in technology transfer
- Determine the cost of GLP non-compliance
- Know 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
- Aware of the critical GLP compliance issues
- Describe the GLP requirements related to organization, personnel, facilities, equipment, operations, testing, control, protocols, records and reports
- Know the scope, the field of application, components & sources of uncertainty and be able to learn how to conduct analytical measurement & experimental studies of method performance
- Review & improve the process of measurement uncertainty estimation and be able to analyze the specification of the measured
- 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
- Understand the 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. This course is intended for all Senior Technician, Chemists Senior Chemists, and other Laboratory Personnel. 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