Webinar Series Annex 1 - New Requirements for Clean Rooms & HVAC Systems
Tuesday, 9 June 2020 10.00 - 11.30 h
Course No. 18064
Speakers
Dr Jean-Denis Mallet
Former Head of the Pharmaceutical Inspection Dpt. AFSSAPS
Important: Deadline is 12 noon on 8 June 2020You will find all webinars of this series in this overview
Background
Annex 1 of the EU GMP Guide “Manufacture of sterile medicinal products” is the most important guideline for sterile manufacturing of medicinal products. It is currently under revision with a first version having been published for public comments in 2017. After thousands of comments had been received a revised version was published in February 2020 which is now open for commentation by selected stakeholders. Many changes can be found in the new document especially when compared to the former official version of the Annex 1. This is also true for the premises, clean rooms and HVAC systems which are necessary to ensure aseptic/sterile conditions.
Target Group
The target group of this webinar are professionals in engineering, production and quality assurance responsible for setting up or operating GMP-compliant premises for the manufacture of sterile medicinal products.
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.
To find alternative dates for this training/webinar or similar events please see the complete list of all events.
For many training courses and webinars, there are also recordings you can order and watch any time. Just take a look at the complete list of all recordings.
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Seminar Programme as PDF