Monitoring and Trending in Quality Control and Production - Online Training Recording

In order to ensure quality, safety, and efficacy of pharmaceuticals, an appropriate control of the capability of the manufacturing process (EU GMP Guide Part 1, Annex 15), as well as of the analytical performance (EU GMP Guide Part 1, Chapter 6, Quality Control (6.16), FDA Method Validation-Guidance) is important, during the whole lifecycle. A regular evaluation is expected, e.g. as Annual Quality Review (FDA, 21CFR 211.180(e)) or Product Quality Review (EU GMP Guide 1.10). Unlike the rules established for investigation of results outside of specification (OOS), no detailed advice is provided by the authorities in case of results outside of expectation or outside of trends. However, this opens up the flexibility to establish suitable monitoring and trending programs of own choice.

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.