Thursday April 25, 2024
12:00 pm – 1:30 pm (NY Time)
Instructor: Ronald D. Snee, PhD
Use of statistics has been part of the FDA’s guidances and regulations for many years. Use of statistics 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:
- 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
Fee:
$385 for one person
$700 2-5 people
$999 6-10 people
Questions? support@eccwebinars.com
ECC-595