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.
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.
- 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 22.07.2020
Duration of the recording: approx. 1.5 h.