Deviations and CAPAs - Conduct effective investigations
This 1-day training focuses on root cause analysis and impact assessment of deviations and identification of appropriate corrective and preventive actions (CAPAs).
Location
Duration
Course fee
Short description
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.
Average score for the previous Deviations and CAPAs course: 8.9 out of 10
Objectives
Upon completion of the training, participants will have acquired the following knowledge and skills:
Knowledge of the factors that are important in determining a valid deviation and why.
Identification of the aspects that must be used when describing a deviation.
Use of various techniques for performing root cause analysis and risk analysis.
Determine appropriate CAPAs.
Set up an effectiveness measurement for a CAPA.
Target group
For whom is the Deviations and CAPAs course recommended?
This training has been developed for production, validation, and technical personnel, as well as individuals working in process development or QC departments. This training is also highly suitable for employees involved in deviation investigations or in the management of a deviation system.
Reviews:
“Good course that lays a very solid foundation for deviations and CAPAs.”
“Very good introduction or refresher training.”
Program
For more information, feel free to contact us.
email to Biotech Training Facility