Solving Statistical Mysteries – What does the FDA want 2019

Solving Statistical Mysteries What does the FDA want 2019 is a webinar provides an overview of what it appears the FDA is looking for in the use statistics.

Topics

• Quality by Design
• Today’s Reality: FDA Guidance Regarding:
• Test Method Development
• Continued Process Verification
• Tools, Methods and Personnel
• FDA Guidance’s – Examples of Recommended use of Statistical Thinking and Methods
• What’s the FDA Looking for?
• What is the Appropriate Documentation?
• Useful Standards
• Right Process Measurement, Data, Tools and Methods and Interpretation
• Tips, Traps and Recommendations
• Understanding of tool usage and interpretation of results

Who should Attend

• Process and Manufacturing Engineers
• Executives and Managers of Pharma and Biotech Companies
• Regulatory Affairs Professionals
• Quality Assurance Personnel
• Quality Engineers
• Quality Control Lab Personnel
• Biologists and Microbiologists
• Research and Development Scientists
• Chemists and Chemical Engineers