Conference Details

This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

Date :

Place : United States, Baltimore

Website :

Contact Person:John Robinson

Description:

This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. will be held in Baltimore,United States on date 2017-04-07

Deadline for abstracts/proposals : 5th April 2017

Organized By :Netzealous LLC

Keynote Speakers : Heath Rushing, Co-founder and Principal, Adsurgo. Heath Rushing is the cofounder of Adsurgo LLC and co-author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses. He created tailored courses, applications, and long-term training plans in quality and sta

Conference Highlights :Agenda: Lecture 1: Introduction to Quality by Design (QbD) Quality by Design (QbD) principles Product Quality System framework Primer on Statistical Analysis basic statistics Lecture 2: Primer on Statistical Analysis (cont.) hypothesis testing Lecture 3: Primer on Statistical Analysis (cont.) ANOVA Lecture 4: Primer on Statistical Analysis (cont.) Regression Day 2 Schedule Lecture 1: Foundational Requirements for QbD Studies Setting specifications Measurement Systems Analysis

Venue :The DoubleTree Baltimore-BWI Airport, 890 Elkridge Landing Road - Linthicum, MD 21090

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This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

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