Dr Nicola Spiggelkötter, Knowledge & Support
The globalization of the pharmaceutical supply chain has created new challenges for the manufacture and supply of medicinal products in various markets. The EU-GDP Guidelines have been extensively revised to take into account the changing nature of the globalized supply chain. The new requirements have been effective since 2013. Since the security of the supply chain is one of the core requirements, the transport of pharmaceuticals has to be checked for suitability.
The requirements for transport verification/transport validation are derived from Annex 15 of the GMP guidelines. Although the requirements have existed for many years, there is still a certain amount of uncertainty about how they should be interpreted and implemented into practice.
This webinar addresses itself to all who want to get a compact and comprehensive overview of current expectations for transport validations. Those are e.g. coworkers and high-level personnel from the following industries:
- Pharmaceutical manufacturers (e.g. logistics and QA)
- Drug wholesaler
- Logistics companies
- External warehouses
- further service providers offering services for the distribution of pharmaceuticals
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.
This webinar aims to give participants a comprehensive yet compact overview of how to do a transport validation.
The topics addressed are:
- Regulatory requirements for a transport validation
- Documentary requirements for a transport validation
- Cluster approach
- Exemplary risk analysis of a transport route