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
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
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 03.07.2020
Duration of recording: about 1,5 h.