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.
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
- Brexit
- 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)
Recording from 18 February 2021
Duration of the Recording: Appr.1,5 h