FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Statistics and statistical methods are mentioned 14 times throughout FDA’s 19-page Process Validation Guidance…
This session will bring you the essentials of navigating the practicalities of Stability statistics. In addition, the day wraps up with a traditional PSDG session where you can ask about the practices of your industry colleagues, statistical or otherwise.
Statistics in Validation
November 14, 2023
10:45 AM – 5:30 PM EST
Virtual, United States
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Statistics and statistical methods are mentioned 14 times throughout FDA’s 19-page Process Validation Guidance…
Stability Statistics for Non-Statisticians
November 15, 2023
10:15 AM – 5:15 PM ET
Virtual
This session will bring you the essentials of navigating the practicalities of Stability statistics. In addition, the day wraps up with a traditional PSDG session where you can ask about the practices of your industry colleagues, statistical or otherwise.