Selecting a CRO to Support GxP Analytical and Bioanalytical
-
Speaker : EDWARD O'CONNOR
-
When : Thursday, July 17, 2025
-
Time : 11 : 00 AM EST
-
Add To Calendar
Refer a Friend
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.
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 skillsets. Development of a rating table to compare 3-5 candidate CRO.
Who Should Attend
- Analysts
- Director
- Managers, and
- QA officers in GCP labs
Why Should You Attend
This course suggests components of CRO selection to limit impacts and reduce delays. The course also strongly supports an objective selection and the component requisites to ensure that the selection and award are objective.
Topic Background
Changing alignments and governance of Contract Research Organizations (CRO) impact availability to meet Sponsor timelines. The selection of a CRO to meet analytical and bioanalytical requirements is directly impacted. A delay in or retraction of a contract may further delay the completion of projects and a delay in meeting timelines for regulatory submission. To avoid or limit impacts, a path forward outlining steps and requirements in CRO selection is presented.
-
$199.00
-
