Dr Afshin Hosseiny
ECA
Referent:innen
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.
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.
donor sites.
Technical Details
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
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:
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
Recording from 06.07.2020
Duration of recording: about 1.5 h.
Duration of recording: about 1.5 h.
| ECA-Member*: | € 199,- |
| Regular Fee*: | € 249,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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