This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents.

Date : 20th April 2017 to 21st April 2017

Place : United States, San diego

Website :http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900806SEMINAR?channel=mailer&camp=Seminar&AdGroup=allconferencealerts_April_2017_SEO

Contact Person:John Robinson

Description:

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents.

This course focuses on how to establish a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance. It begins with a primer on statistics, focusing on methods that will be applied in each remaining chapter. Next, it teaches the application of statistics for setting specifications and assessing measurement systems (assays), two foundational requirements for process validation. Lastly, the course applies statistic through the three stages of process validation defined by requirements in the process validation regulatory guidance documents. will be held in San diego,United States on date 2017-04-21

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Deadline for abstracts/proposals : 19th April 2017

Keynote Speakers : Richard (Rick) K. Burdick, Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He taught at ASU for 29 years at all levels including undergraduate business students, MBAs, Master of Statistics students, and doctoral candidates in both business and engineering. He received numerous teaching awards and taught a variety of courses for adult learners. His research and consulting inte

Conference Highlights :Agenda: Lecture 1: Introduction to Statistics for Process Validation • principles of process validation • stages of process validation Primer on Statistical Analysis • basic statistics Lecture 2: Primer on Statistical Analysis (cont.) • statistical intervals and hypothesis testing Lecture 3: Primer on Statistical Analysis (cont.) • statistical intervals and hypothesis testing • ANOVA Lecture 4: Primer on Statistical Analysis (cont.) • regression • run charts D

Venue :Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego, California, 92101 - United States

Check the event website for more details.