Prabjeet Dulai, GDP & Quality Matters Ltd.
Jonathan Riley, Astellas Pharma Europe Ltd.
The globalisation of the pharmaceutical supply chain has created new challenges for the manufacture and supply of medicinal products in various markets. The expected approach to the application of requirements can sometimes be unclear, especially where master distributors act solely as financial trading organisations where physical handling of products is not directly involved.
The webinar is aimed at WDA / License holder management representatives, Responsible Persons, and personnel in key positions within pharmaceutical trading organisations involved in, and accountable for:
- Financial procurement and supply transactions,
- Quality Assurance activities (i.e. approval of customers, suppliers, vendors),
- Creation and maintenance of IT master data (customer/supplier details),
- Managing the interface with the physical Supply Chain including third party vendors.
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.
- The supply chain model and involvement of marketing authorisation holders in the distribution network.
- The role of WDA / License holder management representatives.
- The role of the Responsible Person when product handling is not involved.
- Quality System; handling of complaints, returns, suspected falsified medicinal products and medicinal product recalls etc.
- Qualification of customers and approval of suppliers.
- Control of outsourced activities and establishment of Quality / Technical Agreements.
- Definition and review of the integrated supply chain (Supply chain mapping).
- Validation of computerised systems, and processes used in financial Distribution.
Recording from 17.08.2020
Duration of recording: about 1,5 h.