Deviations and CAPAs - Perform effective investigations

Short description

Average score for this Deviations & CAPAs training course: 8.9

Why is this Deviations course important?

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

Deviations in pharma 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 not functioning optimally.

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

Objectives

What can you expect from this Deviations and CAPA training?

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

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

Target group

Who should follow the Deviations and CAPAs course?

This training is developed for production, validation, and technical personnel, process development and QC departments, professionals involved in deviation investigations and/or deviation system management.

Reviews: 

"Good course that lays a very solid foundation for and about deviations and Capas"  "very good initiation or refresher of skills".