Webinar Annex 1, The Revised Draft - A Brief Summary
Thursday, 30 April 2020 14.00 - 15.30 h
Course No. 18001
Speakers
Dr. Ingrid Walther
Pharma Consulting Walther
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):
Testimonials