Statistical Issues in Process Validation
*Xiaoyu Dong, FDA Keywords: A manufacturing process needs to be validated before it can manufacture commercial products. The validation study provides assurance of consistent product quality and knowledge of the impact of process parameters on critical quality attributes. Statistical methods play an essential role in process characterization and process validation. In this presentation, we would like to share our review experience in a few process validation studies. In particular, we will talk about the statistical issues in qualification of scale-down model, in design of experiment as well as in identification of design space for both chemical and biological products.
|
Key Dates
-
April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC