Data Analysis in QSR - Techniques and Tools to avoid Warning Letter 2018 is a webinar that covers topics such as:
- The requirements from QSR and the expectations FDA set
- Difference between corrective action and preventive action – a pervasive problem
- Use the GHTF guidance document to design and implement your improvement program
- How to pick the appropriate data analysis techniques from ISO/TR 10017:2003
- Typical data analysis scenarios
- FDA Warning Letters that illustrate the issues device manufacturers face
- Data analysis techniques available in Excel
Data Analysis in QSR - Techniques and Tools to avoid Warning Letter 2018 is intended for:
- Regulatory affairs
- Senior management
- Production
- Quality assurance
- Data analysts
- R&D and engineering
