Thursday 21 November 2019

Assay and Device Validation and Verification: ISO 15189

About

This webinar is in partnership with the Institute of Biomedical Science (IBMS). 

Assay and device validation and verification is important for quality control and tested by UKAS assessors under ISO15189 as part of a laboratory assessment. This webinar aims to support staff in clinical laboratories to improve their service and achieve accreditation, providing real-world examples of best practice in assay and device validation across cellular pathology, molecular and serology.  

The webinar will cover: 

  • Requirements of the ISO 15189 standard and UKAS assessor
  • Difference between validation and verification 
  • Validating and verifying assays (including performance characteristics, limit of detection and other parameters)
  • Validating and verifying new devices and current devices following service or recalibration


Webinar Recording
A recording of the webinar will be made available from Friday 22nd November for up to 4 weeks. If you are unable to join the live webinar you will still have access to the recording however, the live Q&A function will not be available. In order to have access to the recording you will have to register to the webinar.


Who it is suitable for:

This is a must attend webinar for Laboratory Managers, Quality Managers and Biomedical Scientists. It will also be beneficial for those working in assay manufacturing environments or those with regular exposure to clinical diagnostic assays.


Twitter - #ADVV19

  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • RT: There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54
  • There are just two days until our joint webinar with @IBMScience which will be of interest and relevant to those who are currently certified or undergoing recertification to ISO 15189. Secure your place now: https://t.co/onxMHBsuWQ #advv19 https://t.co/8v1rFPrX54

Agenda

11:00-13:00
 

Our speakers will be covering a range of different topics including sessions on the following:
 

  • Validation of Qualitative Tests
  • Validation of physicochemical methods: using SE-HPLC as an example
  • When to verify and when to validate

 

Agenda — full schedule

November 21st, 11:00 - 13:00

Welcome and introduction

Rob Anderson — Division of Infectious Disease Diagnostics, NIBSC

Why are UKAS interested in assay validation and what UKAS are looking for during a site visit

Gavin Dickinson — UKAS Assessment Manager, Medical Laboratories

When to verify and when to validate

David Padley — Infectious Disease Diagnostics Division, NIBSC

Validation of physicochemical methods: using SE-HPLC as an example

Graham Roberts — Division of Biotherapeutics, NIBSC

Validation of Qualitative Tests

Fiona Denham — Tissue Sciences Quality Manager, Viapath Analytics

Panel session

Closing remarks

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Webinar 21.11.19

Speakers

Speakers to be announced shortly

Register

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IBMS Members

£ 49 +VAT

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Non-Commercial / Non-member

£ 83 +VAT

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Commercial

£ 99 +VAT