Laboratory Investigations Relating to Sample Re-Analysis: Covering the Basics Before Being Called Out
Product ID: 701439
- Duration: 60 Min
Why Should You Attend:
Unexpected results in acceptable assays usually reflexively trigger calls for re-analysis by clinical managers or non clinical study directors. Before re-analysis is initiated compromising the sample, investigators must rule out pre-analytical errors, mislabeling, misdosing, delayed or accelerated sampling, subject variables (concurrent meds, fasting compromised, etc). This session will discuss several suggested procedures, hopefully avoiding unnecessary re-analysis. If re-analysis is still indicated at the end of the investigation, this session will suggest procedures.
Areas Covered in the Webinar:
- Conditions and requirements supporting re-analysis by the bioanalytical lab
- Handling results from re-analysis
- Requirements and suggestion for sample re-analysis
- When can the lab initiate re-analysis of a failed sample without Study Director, Medical Monitor or PK/PD investigator request
- Failed run acceptance
- Failed sample acceptance
- Response Shape
- Internal Standard considerations
- Precision requirements
- Replicates and handling results
- Contents of Request for re-analysis from outside lab (Study Director)
- Incurred sample re- analysis
- Formula for calculating agreement
- Replicates and dilutions needed
- Investigations of failures
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies, since sample re-analysis issues will arise across the CRO, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:
- Laboratorians
- Regulatory management
- QA management
- Clinical Research Managers and Associates
- IT personnel
- Consultants
- Study Directors
- Sponsors
Edward O'Connor
Individual Consultant, HJJ
Dr. Edward O’Connor has varied and extensive experience within both experimental and CLIA, GLP, GCP and GMP regulated laboratories. Dr. O’Connor is an recognized expert in both instrumental (LC-MS, LC-EC, LC-PDA) and ligand binding (MSD, ELISA, FLOW) and cell based assays. Molecules include small molecules, peptides, proteins, antibodies, aptamers and both DNA and RNA nucleotides. Dr. O’Connor is also experienced in allometric pharmacokinetics, and the design of in vivo and in vitro bioanalytical assays to reveal mechanism of action, efficacy and toxicity as related to animal and human studies for developing and evaluating pharmaceutical products. Dr. O’Connor uses and teaches the use of in silico techniques and programs (ACD, BLAST, etc.) in the design of both ligand binding assays and LC-MS approaches to accelerate the development of capture and detect moieties as well as chromatographic and mass spectrographic conditions to optimize assay performance.
Dr. O’Connor is a member of the emerging technologies and real time analysis committees of AAPS and has published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. O’Connor has also streamlined vendor selection and management processes, as well as implemented “DOWNTIME” practices to improve efficiency in Bioanalytical labs. Another facet is Dr. O’Connor’s application of statistics to predict cut points (receiver operator curve-ROC) for cell based and neutralization assays.
Dr. O’Connor has been working as an independent consultant in bioanalysis since 2017. A detailed description of his expertise and the services he provides may be obtained from the website www.aegisbioconsult.com.
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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