Deviation Management and CAPA - Online Training Recording

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.

To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.

Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs. In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.