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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
Patron : Dr. Prithvi Mohandas, Managing Director, MIOT Hospitals.
Organising Secretary : Dr. Deepti Jain
Organising Committee : Dr. Nayana T, Dr. lmmanuel, Mrs. Smitha S, Mrs. Arokiya Jeyarani, and Mr. Mahesh.

Faculty
Dr. Cheirmaraj, Mr. Santosh Kumar Potharam, Dr. Deepti Jain, Dr. Immanuel Ratan Stephen, Dr. T. Nayana, Mrs. S. Smitha, Mr. N. Thirumalai, Dr. Nivedhana

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
Date :  5th & 6th December 2024
Venue :  MIOT International (Main Building, HR Training Hall)

Registration Closed. For more Enquiry Contact

Dr. Deepti Jain :  +91 98334 60752
Ms. S. Smitha :  +91 91760 80991
E-mail :  labcme@miotinternational.com