Data Analysis in QSR 2017

Topics

• The requirements from QSR and the expectations FDA set
• The difference between corrective action and preventive action - a pervasive problem
• The GHTF guidance document to design and implement your improvement program
• How to pick the appropriate data analysis techniques from ISO/TR 10017:2003
• FDA Warning Letters that illustrate the issues device manufacturers face

Who should Attend

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