CSA - Computer Software Assurance - Webinar Recording

Although risk-based software validation is already a best practice, many life science companies are still reluctant to reduce validation activities and/or documentation using risk-based decisions. One reason for this is that the relevant software validation regulations are very general and companies

The result is that these companies either do not take a risk-based approach at all or, more often, despite taking a risk-based approach, still focus primarily on extensive validation documentation rather than on risk to the patient or product quality, as well as the software quality itself.

 

A group of life science industry representatives has teamed up with the FDA to launch an initiative to promote a risk-based approach that focuses more on software quality while significantly reduces the documentation burden. The result is what is called Computer Software Assurance (CSA), for which the FDA will publish a related guidance document (Guidance for Industry).

 

In this webinar, you will learn first-hand what CSA is all about from one of the founders of the so-called FDA-Industry CSA Team (FICSA), which created CSA and produced the associated guidance document. You will learn how to integrate CSA ideas into existing validation processes, why you should do so, and what benefits you can expect.

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.