Quality Oversight in Sterile Manufacturing - Online Training Recording

In the „Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing“ published in 2004, the FDA clearly formulated the expectations for Quality oversight. The aim should be to ensure regular and independent checks of the processes and personnel involved in aseptic manufacturing and thus reduce the risk of product contamination. In several warning letters in recent years, companies have been criticised for insufficient „quality oversight“.

In addition, against the background of new or revised European regulations, e.g. Annex 1 or Annex 15,

EU GMP Guide Annex 15 „1.3 ...However, there should be appropriate quality oversight over the whole validation life cycle“.

every European company faces the question of how the American demands for Quality Oversight will also be taken up in the regulatory environment here in the future.

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.

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.