Approach to Method Verification for Quantitative Tests to Fulfill ISO 15189 Requirements
Introduction
This two-day workshop is organised by the MACB and is supported by the Department of Standards, Malaysia. Participants will receive hands-on training on how to perform method verification for quantitative tests. The objective is for participants to have a clear understanding and to be able to independently perform the procedure according to ISO 15189 requirements.
myCPD Points: 10 points for full day workshop.
Date: Monday, 18th – 19th July, 2022
Venue: Dewan Serbaguna, Jabatan Standard Malaysia, Menara Cyber Axis, Jalan Impact, 63000 Cyberjaya
Speaker: Pn Rozita Binti Abdullah, Hospital Sg. Buloh
- MSc in Clinical Biochemistry with Molecular Biology from University of Surrey, Guildford, United Kingdom, 2005
- Various training given since 2006 to Government & Private Hospitals, Universities on Quality Assurance in Clinical Biochemistry, Quality Control Management in Clinical Biochemistry, Method Validation/Verification and Method Comparison, Measurement of Uncertainty, Lot to Lot Verification, MS ISO 15189 Accreditation-Technical Requirements & Internal Audits and Analytical Performance Specification
- Senior Technical Assessor since 2009
Registration Fee:
RM 240 for members
RM 300 for non-members
Payment can be made via cheque or money transfer to Persatuan klinikal Biokimia Malaysia.
Bank: CIMB Bank Berhad
Account Number :80-0860845-9
| Time | Programme (Day One) |
|---|---|
| 9.00 to 9.30 am | Introduction & Basic Concepts for MV |
| 9.30 to 11.00 am | Quality Specification for MV EFLM Model and Hands on calculation of BV derived APS |
| 11.00 to 12.30 am | Imprecision Study Requirement, Data analysis & Interpretation (Hands-on) |
| 12.30 to 2.00 pm | Lunch break |
| 2.00 to 3.30 pm | Method Comparison – Comparison with previous equipment & Periodic comparability study Study Requirement, Data analysis & Interpretation (Hands-on) |
| 3.30 to 5.00 pm | Linearity / Reportable Range Study Requirement, Data analysis & Interpretation (Hands-on) |
| Time | Programme (Day Two) |
|---|---|
| 9.00 to 10.30 am | Detection Limit / Functional Sensitivity Study Requirement, Data analysis & Interpretation (Hands-on) |
| 10.30 to 12.30 am | Reference Interval Verification Study Requirement, Data analysis & Interpretation (Hands-on) |
| 12.30 to 2.00 pm | Lunch break |
| 2.00 to 3.30 pm | Group discussion |
| 3.30 to 4.30 pm | MV Reporting How to write your MV findings/summary report and approach for unacceptable findings |
| 4.30 pm | Summary and Closing |
Thank you for your interest to join the workshop. We are regret to inform you that the number of seats are fully booked. We will organize similar event in the future.