Robert Schwarz, Trainer & Lecturer, Austria
Annex 1 “Manufacture of sterile medicinal products” of the EU GMP Guide is currently being revised. A first draft of the revised version was published in 2017 and released for public comment, resulting in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.
This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
- Quality Assurance and Quality Control
- Engineering & Validation
or who are involved in
- Sterile/Aseptic Manufacturing
- Contamination Control and Monitoring
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 informs you about the current status of the revision with regard to the topic decontamination or decontamination systems. This topic is of increasing importance in the significantly expanded field of contamination control strategies (CCS ), since fumigation and fogging play an important role in connection with room and transfer decontamination. The current draft emphasises that measures for CCS must in many cases be seen in the overall context. Cleaning and decontamination as well as disinfection and sterilisation are not interchangeable, but are supporting pillars of the management of a holistic concept of contamination prevention and control in the production of sterile drugs, active ingredients or packaging materials.
Accordingly, this webinar will cover the following topics:
- Decontamination and regulations
- Selecting the appropriate decontamination agent
- URS and Equipment purchase
- Process Development
- Validation topics
Recording from 25 June 2020
Duration of recording: about 1,5 h.