Repligen: Deviations & CAPA's
This 1-day training focuses on root cause analysis and impact assessment of deviations and identification of appropriate corrective and preventive actions (CAPAs).
Why is this Deviation and CAPA training important?
In the production of pharmaceutical products, unexpected events can occur, for example during production, analysis, storage, transportation or even during equipment qualification and/or calibration.
In the biopharmaceutical industry, these events are called deviations. Deviations can have a negative effect on the quality of pharmaceutical products and may even lead to their recall. Moreover, these deviations can be an indication that the quality system is not functioning optimally.
For these reasons, it is of utmost importance to always investigate deviations. In a deviation investigation, the following aspects are essential:
Root Cause Analysis (RCA) to determine why the deviation occurred.
Impact Assessment (IA) to determine the potential consequences of the deviation.
Identify Corrective and Preventive Action (CAPA) to ensure that appropriate actions are taken to immediately reduce the impact of the deviation, and prevent the deviation from recurring.