Webinar Series Annex 1 - New Requirements for Clean Rooms & HVAC Systems
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| ECA-Member: | EUR 199,-- | |
| Non ECA Member: | EUR 249,-- |
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de
Speakers
Dr Jean-Denis Mallet, Former head of the French Inspection Department AFSSAPS, Pharmaplan
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.
Programme
In this webinar it will be shown where the differences and new requirements are, compared to former versions of the EU GMP Annex 1:
Premises
Premises
- Supervision from outside the critical cleanrooms
- Clarification on the need for several airlocks and the related transfers
- Management of differential pressure (cascade or not)
- The importance of visualisation of the airflow patterns
- Disinfection of cleanrooms
HVAC-Systems
- Electronic particulate counting ... and microbial, too ?
- What is cleanroom classification, cleanroom qualification, cleanroom monitoring?
Equipment
- Anticipating the progressive disappearing of the classical clean rooms
- Sterilization or disinfection of equipment
Utilities
- More detailed requirements from the new Annex 1