Applied Statistics for FDA Process Validation

Date : 15th January 2019 to 16th January 2019

Place : United States, Philadelphia

Website :https://www.globalcompliancepanel.com/seminar/applied-statistics-for-FDA-process-validation-901927SEMINAR?allconferencealerts-seo

Contact Person:Event Manager

Description:

In Guidance for Industry Process Validation: General Principle and Practices, process validation is defined as, ""...the collection and evaluation of data, from the process design stage through commercial production.." The guidance further delineates the 'process design stage through commercial production' into three distinct stages of the product lifecycle: Stage 1: Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities. Stage 2: Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing. Stage 3: Continued Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control. The first stage of process validation is process design. The Process Validation guidance document states, "A successful validation program depends on information and knowledge from product and process development. This knowledge and understanding is the basis for establishing an approach to control of a manufacturing process that results in products with desired quality attributes:

Applied Statistics for FDA Process Validation will be held in Philadelphia,United States on date 2019-01-16

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Deadline for abstracts/proposals : 15th January 2019

Keynote Speakers : Richard (Rick) K. Burdick Emeritus Professor of Statistics, Elion Labs Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU), where he instructed undergraduate and graduate students for 29 years. Following his tenure at ASU, Dr. Burdick was a Quality Engineering Director for Amgen Inc. for 10 years. Dr. Burdick's research and consulting interests consider several CMC statistical applications including comparability studies, stability data an

Conference Highlights :apply statistics to set specifications and validate measurement systems (assays) develop appropriate sample plans based on confidence and power implement suitable statistical methods into a process validation program for each of the three stages Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (

Venue :DoubleTree by Hilton Hotel Philadelphia Airport, Island Avenue, Philadelphia, PA, USA

Check the event website for more details.