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Start Date

4-16-2024 3:30 PM

End Date

4-16-2024 3:45 PM

Description

Abstract

The purpose of a Corrective and Preventive Action (CAPA) investigation is to identify and address errors, deviations, and compliance issues to ensure the integrity, reliability, and quality of research and biomanufacturing. In the biotech industry, where identifying and rectifying root causes of errors is key to ensuring quality data and preventing future errors, CAPA plays a crucial role. The Jefferson Biotechnology (JBT) lab was asked to investigate the sterility of a biotech supplier’s microbiological agar plates, when a client reported contamination in their agar plates, suspecting contamination prior to sleeve opening. By attempting to reproduce our client's results through a CAPA investigation, the JBT lab was able to confirm that the client's plates were not contaminated prior to usage. This validation persuaded the client to implement JBT's advice on aseptic techniques, thereby reducing the risk of unnecessary errors in microbiological handling and offering valuable guidance for future preventive measures.

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Presentation: 9:20

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Apr 16th, 3:30 PM Apr 16th, 3:45 PM

CAPA: Quality Control Testing of Laboratory Plates

Abstract

The purpose of a Corrective and Preventive Action (CAPA) investigation is to identify and address errors, deviations, and compliance issues to ensure the integrity, reliability, and quality of research and biomanufacturing. In the biotech industry, where identifying and rectifying root causes of errors is key to ensuring quality data and preventing future errors, CAPA plays a crucial role. The Jefferson Biotechnology (JBT) lab was asked to investigate the sterility of a biotech supplier’s microbiological agar plates, when a client reported contamination in their agar plates, suspecting contamination prior to sleeve opening. By attempting to reproduce our client's results through a CAPA investigation, the JBT lab was able to confirm that the client's plates were not contaminated prior to usage. This validation persuaded the client to implement JBT's advice on aseptic techniques, thereby reducing the risk of unnecessary errors in microbiological handling and offering valuable guidance for future preventive measures.