Webinar Annex 1, The Revised Draft - A Brief Summary

Webinar Annex 1, The Revised Draft - A Brief Summary

Course No 18001

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Speakers

Dr Ingrid Walther, Pharma Consulting Walther, Former Head of the Business Unit iv Drugs and Oncology, Fresenius Kabi

Background

The Annex 1 “Manufacture of Sterile Medicinal Products” of the EU GMP Guideline is currently under revision. A first draft of the revised version was published in 2017 and open for public comment, which lead to thousands of comments. In February 2020, a revised version has been published, which is open for review and comments by selected interest groups.

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 update on the current status and give an overview of the modifications that have been implemented compared to the 2017 version. Furthermore, it will give some hints how review groups see the updates and which concerns are still persistent.
  • General view of Review Groups
    • positive aspects
    • “difficult” aspects
  • Specific requirements and aspects regarding (examples):
    • Barrier technologies
    • Cleanroom classification and qualification
    • Trending requirements in EM and personnel
    • Aseptic process simulation (media fills)
    • Quality control – sterility testing

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