Deviations and CAPAs - Perform effective investigations

Short description

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 pharmaceutical industry these events are called deviations or non-conformances.

Deviations 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 functioning suboptimally.

For the abovementioned reasons, it is of the utmost importance to investigate these deviations. In such an investigation 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 actions (CAPA), to be sure that correct actions were taken to immediately reduce the impact of the deviation, and to prevent the deviation from re-occurring.

Objectives

At the end of the training, participants have the following knowledge and skills:

• Know which aspects are important for a valid deviation and why
• Identify the aspects to be used when describing a deviation
• Use of various techniques to carry out a risk analysis
• Determine appropriate CAPAs
• Draw up effectiveness measurements for CAPAs

Target group

This training is developed for production, validation, and technical personnel, and people working in process development and QC departments. This training is also very suitable for professionals involved in deviation investigations and/or the management of such a deviation system.