Deviation Management and CAPA - Live Online Training

During this course, you will get to know the principles and discuss all relevant aspects to implement, improve and/ or work with a Deviation Management and CAPA System. Furthermore, you will get to know possibilities and tools to monitor and evaluate your CAPAs.

Things will go wrong from time to time. In the world of pharmaceuticals, we need to ensure that we have robust processes and procedures in place to deal with such situations. When an unplanned event arises it must be handled accordingly.

FDA’s Quality System Guide, recent Warning Letters and EUGMP Chapter 1 clearly emphasise the increasing relevance of a proper deviation management and CAPAs. ICH Q9 on Quality Risk Management and ICH Q10 on Pharmaceutical Quality Systems empower us to handle issues that arise in our daily work on the basis of risk analysis.

In any case a sound failure investigation is the key to identify appropriate CAPAs. Here it is also important to know how to deal with human error based and non-human error based non-conformances.

Independent from that, it needs to be pointed out that CAPA is an excellent Quality Management tool to continuously improve processes and avoid future failures. All personnel involved in the management of deviations and CAPAs should aim to identify opportunities for further improvement.

We use Webex Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/onlinetraining- technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.