Identification and Management of OOT and OOS Results - Online Training Recording

Although the FDA-Guidance on OOS-results provides detailed instructions how to manage results outside specification, observations and deficiencies dealing with OOS results is still a major issue in inspections, FDA 483s and Warning Letters.

In the speaker’s experience, an important aspect is to establish a clear terminology to facilitate understanding of the investigation phases and the appropriate testing approaches.

Of course, “prevention is better than cure”. For this purpose, it is important to avoid OOS-results, for example by means of a suitable identification of atypical or out-of-trend (OOT) results. The participants will learn how to identify OOT-results and how to establish suitable OOT-limits

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.