Webinar Annex 1, The Revised Draft - A Brief Summary
Course No 18001
Costs
ARE YOU INTERESTED IN THIS SEMINAR?
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Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org
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.
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
GMP Conferences by Topics
- Quality Assurance
- GMP in Biotechnology
- Microbiology
- Regulatory Affairs
- GMP in Pharmaceutical Development
- Quality Control
- GDP
- Sterile / Aseptic Manufacturing
- Computer Validation
- Validation
- Technical Operations
- GMP for APIs and Excipients
- Medical Devices
- GMP Basic Training Courses
- Packaging
- Data Integrity