Big Data – Tools and Trends for Improving your Quality System

Data, data everywhere. In today’s world, we have access to tremendous amounts of data. Yet, it is difficult to translate this data into useful information. Translating data into meaningful information is a capability that can be a competitive strength in improving quality and compliance. Data Management and Quality metrics can help you with forecasting, resource allocation, risk management, decision making, and continuous improvement.

Bad data means bad decisions! Management Review is one of the fundamental requirements of a suitable quality system. And it relies on timely, accurate and complete information to make risk-based decisions.

Areas Covered in the Session :

• What metrics are needed for quality and compliance success
• Sources of data
• Analytics capabilities
• Descriptive and Predictive Data
• Structure and process for managing data
• Data Governance
• Data Preparation
• Using data for forecasting, continuous improvement, and management review

Who Should Attend:

• Quality Departments
• Compliance Departments
• Internal Auditors
• Quality Systems Specialists
• IT Departments
• CAPA Specialists
• Regulatory Affairs Departments
• Management Representatives
• Process Owners wishing to monitor and improve their processes
• General Managers wanting to reduce Quality and Compliance Risk

Course Director: Susanne Manz

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.