This webinar provides some practical and useful answers to the question
'What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?'
FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. 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 presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.
Today’s Reality: FDA Guidance Regarding:
'What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?'
FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. 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 presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.
Why Should You Attend:
What a Participant will learn:Today’s Reality: FDA Guidance Regarding:
- Quality by Design
- Continued Process Verification
- Test Method Development
- FDA Guidance’s - Examples of Recommended use of Statistical Thinking and Methods
- Tools, Methods and Personnel
- What is the Appropriate Documentation?
- 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
Areas Covered in the Webinar:
- What the FDA is looking for in the use statistics
- Mistakes pharma and biotech companies frequently make in the use of statistical thinking and methods
- Most frequently used statistical tools: Control charts, capability and performance indices, design of experiments, graphical methods, etc.
- What works and what doesn’t work
- Information and ideas on approaches that have worked in a variety of situations
- Problems to be on the lookout for and useful solutions
- What are the most useful graphical and data visualization methods
Who Will Benefit:
- Regulatory Affairs Personnel
- Department Managers
- Quality Assurance Personnel
- Quality Engineers
- Process and Manufacturing Engineers
- Research and Development Scientists
- Biologists and Microbiologists
- Chemists and Chemical Engineers
- Supply Chain Professionals
- From the Pharma and Biotech Industries
- Free Materials:
- Copies of slides of presentation
Course Provider
Ron Snee,