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:
Who Will Benefit:
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.
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