Dr Christian Grote-Westrick, B. Braun Avitum
A lot has happened since the introduction of the revised EU GDP guidelines. The expectations of the authorities have become clearer, experience has been gained and there is much support from associations such as the European GDP Association. In order to get an overview, this webinar was developed.
This webinar addresses itself to all, which are involved in the range of the distribution of medicaments. 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 plugin. 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 current requirements and latest developments in GDP:
- GDP Compliance: Overview of requirements, responsibilities and necessary documents/SOPs
- News from the world of GDP: Regulatory changes
- News from the European GDP Association: Current activities and publications
- GDP for APIs (GDP for Active Substances Guidance)
- Interesting cases from GDP inspections: Hazards and how to avoid them
- Warning letters
- Non-Compliance Reports
- Case study: GDP requirements for storage and transport of deep-frozen pharmaceuticals (mRNA vaccine at -80 °C)