Deviations and CAPAs - Perform effective investigations
This one-day course focuses on the root cause analysis and impact assessment of deviations and the determination of appropriate corrective and preventive actions.
- 1 day
- Course fee
- € 795 (excl. VAT)
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.
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
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.
Wilma Meijs (Wilma Meijs Farmaceutisch Advies BV)
Description of the event
• What are important inputs for a CAPA system?
Analyses of the Root Cause
The following different methods for root cause analyses will be explained and practiced:
Performing an Impact Assessment
• How to make a quick estimate of the impact of the event?
Determining and implementing Corrective and Preventive Actions
• What are “immediate” corrective actions?
- Tue 14 May
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