🎯 Course Description:
This 5-day advanced course provides a comprehensive understanding of method validation as required under ISO/IEC 17025:2017, specifically for laboratories in the oil & gas sector. Participants will explore the principles of method validation, key performance characteristics, and statistical tools to confirm that analytical methods are fit for purpose.
This course includes real-life examples, petroleum product case studies, and hands-on workshops to ensure that attendees can confidently plan, perform, and document method validation activities for both standard and in-house methods.
👥 Who Should Attend:
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Laboratory chemists and analysts
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Quality assurance and QC professionals
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Technical managers and supervisors
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Lab accreditation and compliance officers
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R&D personnel involved in test development
🗓️ Day 1: Introduction to Method Validation
| Time | Topic |
|---|---|
| 08:30 – 09:00 | Welcome, Introductions & Course Objectives |
| 09:00 – 10:30 | What is Method Validation? – Definitions, purpose, and scope |
| 10:30 – 10:45 | ☕ Coffee Break |
| 10:45 – 12:15 | Regulatory & ISO 17025 Requirements for Method Validation |
| 12:15 – 01:15 | 🍽 Lunch Break |
| 01:15 – 02:45 | Types of Methods – Standard, non-standard, and in-house methods |
| 02:45 – 03:00 | ☕ Coffee Break |
| 03:00 – 04:30 | Workshop: Selecting a method to validate for a petroleum product |
🗓️ Day 2: Performance Parameters and Planning
| Time | Topic |
|---|---|
| 08:30 – 10:00 | Key Validation Parameters – Accuracy, precision, linearity, etc. |
| 10:00 – 10:15 | ☕ Coffee Break |
| 10:15 – 12:15 | Creating a Validation Plan – Objectives, scope, and timelines |
| 12:15 – 01:15 | 🍽 Lunch Break |
| 01:15 – 02:45 | Statistical Tools in Validation – Standard deviation, RSD, bias |
| 02:45 – 03:00 | ☕ Coffee Break |
| 03:00 – 04:30 | Case Study: Fuel analysis method validation plan |
🗓️ Day 3: Practical Implementation and Data Analysis
| Time | Topic |
|---|---|
| 08:30 – 10:00 | Precision & Repeatability Studies |
| 10:00 – 10:15 | ☕ Coffee Break |
| 10:15 – 12:15 | Linearity & Range Assessment using calibration curves |
| 12:15 – 01:15 | 🍽 Lunch Break |
| 01:15 – 02:45 | Limit of Detection (LOD) & Limit of Quantitation (LOQ) |
| 02:45 – 03:00 | ☕ Coffee Break |
| 03:00 – 04:30 | Workshop: Analyzing sample data from GC or sulfur analysis |
🗓️ Day 4: Documentation and Compliance
| Time | Topic |
|---|---|
| 08:30 – 10:00 | Documenting Validation Results – Templates, reports, conclusions |
| 10:00 – 10:15 | ☕ Coffee Break |
| 10:15 – 12:15 | Validation vs Verification – When and how to verify methods |
| 12:15 – 01:15 | 🍽 Lunch Break |
| 01:15 – 02:45 | Audit Expectations – What assessors look for in method validation |
| 02:45 – 03:00 | ☕ Coffee Break |
| 03:00 – 04:30 | Workshop: Preparing a validation report for submission |
🗓️ Day 5: Troubleshooting and Continuous Improvement
| Time | Topic |
|---|---|
| 08:30 – 10:00 | Troubleshooting Method Issues – Root cause analysis |
| 10:00 – 10:15 | ☕ Coffee Break |
| 10:15 – 12:15 | Improving Existing Methods – Optimization strategies |
| 12:15 – 01:15 | 🍽 Lunch Break |
| 01:15 – 03:00 | Validation of Modified Methods |
| 03:00 – 03:15 | ☕ Coffee Break |
| 03:15 – 04:30 | Final Q&A, Presentations, Feedback & Certificate Distribution |
📂 Course Materials Provided:
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Method validation plan and report templates
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ISO/IEC 17025:2017 clause summary related to validation
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Statistical analysis worksheets (Excel-based)
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Real-world case studies (GC, distillation, sulfur methods, etc.)
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Validation checklist for audits and internal reviews
