Webinar Series Annex 1 - Requirements for Personnel in the Context of the Contamination Control Strategy
Course No 18166
Important: Deadline is 12 noon on 16 September 2020
All times mentioned are CEST.
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Speakers
Dr Bettina Rietz-Wolf, GMP Inspector for EMA and local Government, Germany
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, resulting in thousands of comments. A revised version was published in February 2020 and is open for limited comment by selected stakeholders.
Target Group
The webinar is aimed at managers and employees from the pharmaceutical and biopharmaceutical industries, who want to get a compact and comprehensive overview of the current requirements in the new Annex 1 with focus on personnel.
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 current status of the revision with regard to the topic of personnel in conjunction with contamination control (CCS Contamination Control Strategy). The current draft emphasizes in many cases that the networking and coordination of the individual measures, from design of airlocks to personnel clothing and gowning to personnel training and up to appropriate monitoring, is crucial for success and they must result in a coherent and coordinated overall concept. Accordingly, this webinar covers the core requirements:
- Requirements for personnel in the context of Contamination Control Strategy
- Air locks for Personnel
- Protective garments
- Qualification and Disqualification
- Gowning Qualification
- Monitoring of personnel
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