This webinar provides an overview of what it appears the FDA is looking for in the use statistics by taking illustrative examples from warning letters and industry experiences and approaches that have worked in a variety of situations.
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 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.
Learning Objectives :
To have a complete understanding of what the FDA is requiring pharma and biotech companies to do regarding the use of statistical thinking and methods and what statistical concepts, methods and tools that can be used to satisfy the FDA requirements.
Key Take Away :
Awareness and understanding of what the FDA is looking for in the use statistics
Understanding of what works and doesn’t work
Obtain information and ideas on approaches that have worked in a variety of situations
Areas Covered in the Session :
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
Who Should Attend:
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