Webinar Series Annex 1 - Application of Disinfectants and their Validation
Thursday, 9 July 2020 14.00 - 15.30 h
Course No. 18068
Speakers
Dr. Thomas Meindl
Labor LS
Important: Deadline is 12 noon on 8 July 2020You will find all webinars of this series in this overview
Background
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, which resulted in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.
Target Group
This conference is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in
Contamination Control, Monitoring, Qualification and Validation, Self Inspection, Quality Affairs, Process Simulation/Media Fill
Technical Requirements
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.
Programme
This webinar will inform you about the requirements for the use of disinfectants in pharmaceutical production, which are formulated in more detail in the new Annex.
Starting from a qualified cleaning, a disinfection strategy must be developed and validated as part of the Contamination Control Strategy. The validation shows that the methods, processes and materials described lead to the desired result under the individual clean room conditions. An important prerequisite for this is up-to-date data on the respective house germ flora. The selection of disinfectants is based on the results of operational hygiene monitoring as well as on risk-based approaches, which can be used to plan the frequency of use and the selection of disinfectants.
Inhouse Isolates as a basis for decision-making for a risk-based approach
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