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


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: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • RT: Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf
  • Our full speaker line up and their presentation titles have just been announced for our webinar in partnership with @IBMScience. Do you have regular exposure to clinical diagnostic assays? View the full programme for our ISO 15189 webinar: https://t.co/uC23RJYCm7 #advv19 https://t.co/UsFw3HUesf

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