Data Analysis in QSR - Techniques and Tools to avoid Warning Letter 2018

Topics

• 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

Who should Attend

• Regulatory affairs
• Senior management
• Production
• Quality assurance
• Data analysts
• R&D and engineering