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
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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
Recording from 28 September 2020.
Duration of recording: 1.5 h.