CONNECT MIOT
Workshop on Method Verification Based on CLSI Guidelines
Method verification (MV) is a laboratory process of ensuring that an established or standardised analytical method works effectively under specific conditions of lab and can be used reliably for its intended purpose. This mainly helps in generating reliability of test results produced. Ensuring accurate and consistent results is critical for quality control, regulatory compliance and maintaining the integrity of test processes.
CLSI’s Method Evaluation standards provide concise explanations and step-by-step instructions for evaluation of test method performance characteristics and MIOT being the member of Clinical Laboratory Standards Institute ( CLSI), USA, we mainly focuses on the basic parameters performed in any laboratory as part of verification of a new method introduced in lab for testing. MV also has become a mandate as per ISO 15189:2022 guidelines and NABL 112:2019 and is part of good laboratory practice.
Program Schedule
Time |
Topic/Activity |
|---|---|
| DAY 1 | |
| 08.30AM – 09.00AM | Registration |
| 09.00AM – 09.30AM | Welcome & Key note address. |
| 09:30AM – 10:00AM | Method Validation and Verification – An Overview. |
| 10:00AM – 10:45AM | CLSI Guidelines EP15 A3 – User Verification of Precision | 10:45AM – 11:00AM | Tea Break |
| 11:00AM – 11:45AM | CLSI Guidelines EP15 A3 – Bias Estimation |
| 11:45AM – 12:45PM | CLSI Guidelines EP15 A3 – Precision & Accuracy Verification – Hands on Experience |
| 12:45PM – 01:30PM | Lunch Break |
| 01:30PM – 02:15PM | CLSI Guidelines EP 06 ED2 – Evaluation of Linearity of Quantitative Measurement procedure |
| 02:15PM – 03:00PM | Linearity Verification – Hands on Experience |
| 03:00PM – 03:45PM | CLSI Guidelines EP 09 – A3 – Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved. Guideline — Third Edition |
| 03:45PM – 04:00PM | Tea Break |
| 04:00PM – 04:45PM | Method Comparison – Hands on Experience |
| DAY 2 | |
| 09:30AM – 10.30AM | CLSI Guidelines EP28A3c – Define and verify reference intervals in lab |
| 10.30AM – 10.50AM | Tea Break |
| 10.50AM – 11.40AM | EP12-A2:User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline-Second Edition |
| 11.40AM – 12.00PM | Hands on experience | 12.00PM – 12.40PM | EP47 Ed1:Evaluation of Reagent Carryover Effects on Test Results, 1st Edition |
| 12.40PM – 01.00PM | Discussion |
| 01.00PM – 02.00PM | Lunch Break |
| 02.00PM – 03.00PM | H26-A2:2010 Validation, Verification, and Quality Assurance of Automated Hematology Analyzers, 2nd Edition |
| 03.00PM – 03.30PM | Open discussion |
| 03.30PM – 04.00PM | Certificate distribution followed by high tea |
Organising Secretary : Dr. Deepti Jain
Organising Committee : Dr. Nayana T, Dr. lmmanuel, Mrs. Smitha S, Mrs. Arokiya Jeyarani, and Mr. Mahesh.
OBJECTIVES OF THE WORKSHOP
- Understand the concept of method verification
- Familiarise with the regulatory guidelines
- Equipping participants with knowledge and practical skills necessary to verify analytical methods effectively in their own laboratories.
- Data analysis and interpretation
- Prepare MV documentation
LEARNING METHODS
- Interactive sessions
- Hands on activities aiding the verification process
WHO CAN PARTICIPATE?
- Lab Directors, Pathologists, Biochemists, Microbiologists, Lab managers, Quality control professionals and senior laboratory technical officers
Workshop Details |
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Date : 5th & 6th December 2024 Venue : MIOT International (Main Building, HR Training Hall) |
For Registration and Enquiry Contact |
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Dr. Deepti Jain : +91 98334 60752 Ms. S. Smitha : +91 91760 80991 E-mail : labcme@miotinternational.com |
