Dr Nicola Spiggelkötter, Knowledge & Support
The risk-based approach is a fundamental requirement for processes in the GDP environment. Quality risk management is one of the mandatory basic elements. It is applicable to a variety of activities and processes such as temperature mapping studies, supplier qualification, deviations and change control.
This webinar addresses itself to all who want to get a compact and comprehensive overview of current expectations about quality risk management at GDP. 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 the concept and the implementation of a risk-based approach.
The topics addressed are:
- Regulatory requirements for quality risk management (QRM) in the GDP environment
- Application of QRM in the qualification of service providers
- Application of QRM in the qualification of facilities
- Application of QRM for deviations, CAPAs and change control