Use of statistics has been part of the FDA’s guidance and regulations for many years. Recent uses include Quality by Design, Process Analytical Technology and the 2011 FDA Process Validation Guidance. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many.
This webinar addresses how to effectively use statistical thinking and methods by providing a process for planning, conducting, documenting and reporting statistical analyses. This “process” includes: the critical steps involved, how to use visualization to analyze and report results, the most frequently used statistical tools and the most useful graphical and data visualization methods. Roadmaps are provided, critical steps are identified and illustrative examples and case studies are provided.
- Today’s Reality: FDA Guidance Regarding:
- Quality by Design and Process Validation
- Examples of Recommended use and reporting of Statistical Thinking and Methods
- What’s the FDA Looking for?
- Right Process Measurement, Data, Tools and Methods and Interpretation
- Useful Standards
- Understanding of tool usage and interpretation of results
- “Process” of Planning, Conducting, Documenting and Reporting Statistical Analyses
- Tips, Traps and Recommendations
- Quality Assurance Departments
- Regulatory Affairs
- Quality Departments
- Research & Development Scientists
- Manufacturing Departments
- Quality Control Lab Personnel
- Engineering Departments
- Production Departments
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Process Engineers
- Everyone who collects, analyzes and reports data as part of their work responsibilities