Basic principles Deviations & CAPA

Purpose

In the manufacture of pharmaceutical products, unexpected events can occur, for example during production, analysis, storage, transportation or even during equipment qualification and/or calibration. In the pharmaceutical and food industry these events are called deviations or non-conformances. These deviations can have a negative effect on the quality of the products and can even lead to product recalls. Upon investigation, Corrective and Preventive Actions (CAPA) can be established to ensure that appropriate actions are taken to immediately mitigate the impact of the deviation and prevent the deviation from recurring.

Target Audience

Employees at various company levels (QA, QC, QS), but also at departmental level and who are directly or indirectly involved in managing or working on operational activities.

Intent

This training consists of 1 half day (4 hours) and deals with the diversity of different deviations, how to deal with this and when is a CAPA created.

Programma

·        Introduction Deviation and CAPA.

·        Aspects to determine a deviation

·        Perform Impact Assessment

·        Describe a deviation

·        Techniques perform risk analysis

·        Define CAPA

·        Set up effectiveness measurement for a CAPA

 Qty participants   8 - 12