Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements

Instructor: Edward O Connor
Product ID: 706498
  • 22
  • July 2020
  • 08:00 AM PDT | 11:00 AM EDT
    Duration: 60 Min
Sample re-analysis can be a quagmire of decision and indecision. Incurred sample re-analysis is required in regulated labs, but resolution of disparate results can be another difficult area. Pre-analytical issues- including mislabeling or absent sample as well as analytical issues add a measure of difficulty as well. This presentation will address these issues and help formulate acceptable resolutions.

Live Online Training
July 22, Wednesday 08:00 AM PDT | 11:00 AM EDT | Duration: 60 Min

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Read Frequently Asked Questions

Why Should You Attend:

This presentation will illustrate common pitfalls in sample re-analysis, how to avoid and address them, ensuring that projects will have minimum risk associated with these areas and errors. Attendees will be presented with strategies either to reduce or mitigate risks associated with sample re-analysis, whether for required retest or requested retest.

Sample Re-analysis may be driven by regulatory requirements, laboratory SOPs and protocols and by Sponsors requests. To lessen the impact on the labs, clearly described instruction and directives must be in existence before the incident occurs. Thes include SOPS covering incurred sample analysis-and describe which samples (Dose-timepoint) should be include, what the acceptance criteria is and how failures should be investigated and reported.

Routine re-analysis that is failures due to an individual sample not meeting prescribed precision requirements or due to an assay failure must also be described clearly.

Lastly, the re-analysis of sample which meet acceptance criteria as a sample and as part of an assay must be definitively prescribed. This case should be removed from the laboratory and should only be driven and attributed to the sponsor. Labs must not re-analyze samples simply because the result does not “look right”.

This presentation will provide strategies and instructions to deal with each of the cases for sample re-analysis, and which will reduce the risk of failure for each case.

Areas Covered in the Webinar:

  • Ensuring success in sample re-analysis
  • Stability of Analyte
  • Stability of Sample
  • Questions and Solutions for failed Incurred Sample Re-analysis
  • Protecting the Lab with Protocols and SOPs about requested reanalysis
  • Preventing the LAB from reflex retesting of “ODD Results”
  • Justifying Re-analysis based on mis identification/labeling of sample
  • Re-analysis due to analyst error

Who Will Benefit:

  • Laboratorians in regulated labs
  • Lab directors, Managers
  • QA/QC professionals
  • Principal Investigators and Study Directors (Bioanalytical, Clinical and Non-Clinincal)
  • Pharmaceutical and Biotech, CRO, CMO

Free Materials:

  • Calculation for re-analysis
  • FDA and EMA Guidance documents
  • Checklist for lab before committing to re-analysis
  • SOP suggested contents
  • Easy fill in forms
  • FDA warning letters and 483 re re-analysis
Instructor Profile:
Edward O'Connor

Edward O'Connor
Individual Consultant, HJJ

Dr. O’Connor has been a Director, Manager and Consultant in regulated Analytical and Bioanalytical laboratories in Pharma, Biotech and CROs for over 25 years. He has had direct involvement in lab relocation and design, method development, method, process and instrument/equipment validation.

Follow us :
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
Quality Control Laboratory Compliance

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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