Webinar Series Annex 1 - Contamination Control Strategy and Monitoring

Costs

*ECA-Member:**	EUR 199,--
*Regular Fee:**	EUR 249,--

(All prices excl. VAT). Important notes on sales tax.

Registration

* also payable by credit card

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Speakers

Dr Rainer Gnibl, 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

This Webinar is of interest to professionals from pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibilities in

Quality Assurance and Quality Control
Inspection and Auditing

or who are involved in

Sterile/Aseptic Manufacturing
Contamination Control and Monitoring
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 current status of the revision with regard to the significantly expanded topic of contamination control (CCS Contamination Control Strategy). The current draft emphasizes in many cases that the networking and coordination of the individual measures, from cleaning and disinfection to personnel and clothing 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:

Environment
Personnel
Process Simulation/Media Fill

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