Sample Re-Analysis: Considerations for Incurred, Analytical and Pre-analytical requirements
Instructor:
Edward O Connor
Product ID: 706498
- Duration: 60 Min
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
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.
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
