Annex 1 - The Revised Draft - A Brief Summary - Webinar Recording

Annex 1 - The Revised Draft - A Brief Summary - Webinar Recording


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Dr Ingrid Walther, Pharma Consulting Walther, Former Head of the Business Unit iv Drugs and Oncology, Fresenius Kabi


The Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guideline is currently under revision. A first draft of the revised version was published in 2017 and open for public comment, which lead to thousands of comments. In February 2020, a revised version has been published, which is open for review and comments by selected interest groups.

Target Group

This webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
  • Quality Assurance and Quality Control
  • Inspection and Auditing
or who are involved in
  • Sterile/Aseptic Manufacturing
  • Contamination Control and Monitoring
  • Process Simulation/Media Fill

Technical Details:

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.


This webinar will update on the current status and give an overview of the modifications that have been implemented compared to the 2017 version. Furthermore, it will give some hints how review groups see the updates and which concerns are still persistent.
  • General view of Review Groups
    • positive aspects
    • “difficult” aspects
  • Specific requirements and aspects regarding (examples):
    • Barrier technologies
    • Cleanroom classification and qualification
    • Trending requirements in EM and personnel
    • Aseptic process simulation (media fills)
    • Quality control – sterility testing

Recording from 30 April 2020
Duration of recording: 1,5 h.

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