Webinar Series Annex 1 - Quality Risk Management using the example of the Contamiation Control Strategy
Thursday, 23 July 2020 14.00 - 16.00 h
Course No. 18111
Speakers
Dr. Franz Schönfeld
Regierung von Oberfranken
Important: Deadline is 12 noon on 22 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 second version was published in February 2020 and is open for limited comment by selected stakeholders.
Target Group
This webinar is addressed to employees of pharmaceutical and biopharmaceutical manufacturers, authorities and suppliers with responsibility in
Quality assurance and quality control
Inspections and audits
or who are active in
Sterile/aseptic production
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 teaches the basics of quality risk management and its practical application using the example of contamination control (CCS Contamination Control Strategy) according to the current draft for the revision of Annex 1 of the EU GMP guidelines. It explains the importance and the networking of risk-minimizing measures in the areas of personnel, design and processes within the overall concept of avoiding microbial contamination for the efficient planning and production of sterile dosage forms. Accordingly, this webinar covers the core requirements for
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