Deviations and CAPAs – Perform effective investigations

Description

This one-day course focuses on the root cause analysis and impact assessment of deviations and the determination of appropriate corrective and preventive actions (CAPAs).

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When manufacturing pharmaceutical products, unexpected events can occur, for instance during production, analysis, transport, storage or even during the qualification and/or calibration of equipment. In the biopharmaceutical industry these events are called deviations or non-conformances.

Deviations in pharma could have a negative effect on the quality of the pharmaceutical products and could even result in a recall of the products. Furthermore, these deviations could be an indication that the quality system is not functioning optimally.

For the abovementioned reasons, it is of the utmost importance to always investigate these deviations. In such deviation investigations the following aspects are essential:

root cause analysis: to determine why the deviation occurred.
impact assessment: to determine the (possible) consequences of the deviation
define corrective and preventive action (CAPA), to be sure that correct actions are taken to immediately reduce the impact of the deviation, and to prevent the deviation from re-occurring.

Deviations and CAPAs – Perform effective investigations