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 :
Areas Covered in the Session :
Today’s Reality: FDA Guidance Regarding:
Who Should Attend: