Webinar Fundamentals of Poduct Transfer

Webinar Fundamentals of Poduct Transfer

Seminar Nr. 18072


Kosten

ECA-Member: EUR 199,--
Non ECA Member: EUR 249,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Dr Afshin Hosseiny, ECA &  Former  Director QA at GSK

Hintergrund

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.

Zielgruppe

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

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.

Programm

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

Zurück

GMP Seminare nach Thema

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