Conducting, Documenting and Reporting Statistical Analysis
Duration: 90 Minutes
Use of statistics has been part of the FDA's guidance and regulations for many years. Use of statistical tools is an integral part of the Quality by Design and Process Analytical Technology promoted by the FDA. The Jan 2011 FDA process validation guidance has statistical thinking and methods at its core. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. 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 in pharma and biotech studies and provides an overview of the process of planning, conducting, documenting and reporting statistical analysis. Roadmaps are provided to identify the critical steps in this process. The approaches, concepts, methods and tools are illustrated with case studies and examples for pharma and biotech studies.
Objectives of the Presentation
Why Should you Attend
- What the FDA is looking for in the use statistics
- Awareness of the "process" of planning, conducting, analyzing, and reporting of statistical studies
- Critical steps in planning, conducting, analyzing, and reporting of statistical studies
- How to use visualization to analyze and report results
- Most frequently used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc
- What are the most useful graphical and data visualization methods
- Tips and Traps for what works and doesn't work
- Obtain information and ideas on approaches that have worked in a variety of situations
- Problems and mistakes to be on the lookout for and useful solutions
To have an overall understanding of the "process" of planning, conducting, analyzing, and reporting of statistical studies including: the critical steps in the process, how to use visualization to analyze and report results, the most frequently used statistical tools and the most useful graphical and data visualization methods. This webinar will provide the participants of what is required to successfully use statistical thinking and methods in data-based investigations.
Who will Benefit
- Use of statistical thinking and methods
- What are the appropriate planning, conduct, analysis and documentation of statistical studies?
- FDA guidance's - Examples of recommended use of statistical thinking and methods
- Quality by design
- Continued process verification
- Test method development
- Tools, methods and personnel
- 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
- Tips, traps and recommendations
- Executives and Managers of Pharma and Biotech Companies
- Process and Manufacturing Engineers
- Quality Assurance Personnel
- Regulatory Affairs Professionals
- Quality Control Lab Personnel
- Quality Engineers
- Research and Development Scientists
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Anyone who collects, analyzes and reports data as part of their work responsibilities