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Speaker Profile
EDWARD O'CONNOR

Edward O’Connor has over 25 years in GxP labs as director, associate director of labs. In that capacity he has directed method development and method, software, process, instrument and computer system validation and as QA Manager in Pharma, Biotech and CROs in same. Dr. O’Connor also managed the selection of several CRO to support analytical and bioanalytical work supporting GMP, GLP and GCP projects.


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$199.00
Clinical Sample Analysis: Considerations for the Bioanalytical Lab

 Edward O'connor
 June 17 2025
 11 : 00 AM EST    
 60 Minutes
Clinical Sample Analysis: Considerations for the Bioanalytical Lab

Reviews the history of the GCPs from Tuskegee to Nuremberg, Helsinki to the current 21 CFR and other protections, demonstrating the evolution of the regulation's current status. Particular focus will be on constraints, including requirements for informed consent and the disposition of samples. Several illustrations of recent violations will be provided, along with the consequences. Areas CoveredEvolution of..

$199.00
Selecting a CRO to Support GxP Analytical and Bioanalytical

 Edward O'connor
 July 17 2025
 11 : 00 AM EST    
 60 Minutes
Selecting a CRO to Support GxP Analytical and Bioanalytical

This Webinar suggests objective components in the selection of CRO.Components include inspection and rebuttal of warning letters and 483 issued by the FDA or other regulatory entity, and answers/defense of the same by the CRO.  Areas Covered    Philosophy of the CRO to meet regulatory requirements, interpretation of suitability exercises. Philosophy of training skills and skill..

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Showing 1 to 2 of 2 (1 Pages)