The changing nature of the business strategies of pharmaceutical companies necessitates intra- and intercompany product transfers. This can happen at any stage in the product life-cycle. A transfer project has to make sure, that the receiving site manufactures product with the same quality as the donor site. But this is only one aspect of the interdisciplinary requirements of a product transfer. For an approval of the receiving site, the regulatory strategy has to be defined and the required documents have to be submitted. Maybe new equipment has to be set up and qualified. The transfer of the analytical methods, stability studies, raw materials & packaging components and logistics have to be considered as well. This means that a transfer cannot be handled by a single-person and a cross-functional transfer teams has be installed as a first step in a transfer project. As interests and expertise are quite different within the team it is further essential to understand the project in its entirety and the tasks and deliveries of the single sub-teams. This is especially true for the transfer project leader.
Target Group
This course addresses to staff from Production, Quality Assurance, Regulatory Affairs and Project Management in charge of site changes. This involves project team members, from receiving sites as well as from donor sites.
Technical Requirements
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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.
In this webinar you will learn what the important steps in a product transfer are, how a transfer project is structured and what the GMP relevant deliverables are:
Product transfer – what is it and why would you do it
Different types of transfer
Key steps in product transfer:
Transfer team & plan
Project management
Regulatory compliance – variations and dossier changes
Process transfer
Analytical method transfer
Validation – what we need to do
Stability studies
Finalisation and launch from the new site.
Documentation: useful documents and ‘must have’ GMP documents
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Testimonials
Seminar Programme as PDF