Understanding the Role of Applied Statistics in Pharmaceutical Process Monitoring and Control

Engineering and Validation

Operations

rd

Target Level

• Management
• Research and Development
• Quality Assurance, Validation, and Process Engineers.
• Quality Control
• Production Management and Supervisors

Description

Objectives and Expected Results

Upon completion of this course, participants will be able to

• Use statistics to specify accuracy and variation of a process.
• Use control charts to understand process performance, process monitoring, trouble-shooting and categorize out-of-control process.
• Identify assignable and special causes of variation.
• Outline strategy for process improvement.
• Provide the quality assurance/ quality control with scientific tools to better present the Annual Quality Review Report.
• Successful Completion of this course will prepare the participants for advance statistical methodologies such as Correlation and Regression, Design of Experiments, and Response Surface.

Successful Completion of this course will prepare the participants for in depth understanding of the Quality by Design, Risk-Assessment and analysis.

Others Training Materials

Target group

This course is intended for the pharmaceutical industry professionals with minor or no previous exposure to statistics.  It is designed to provide the participants with strong foundation of the basics and advanced principles of the pharmaceutical statistical applications.  The course is divided into three modules. Module 1: Statistical Concepts to Understanding Statistical Analysis focuses on integrating the theoretical principles of statistics with real-life examples related to various functions within the pharmaceutical industries.  It will cover the essential statistical tools that would enable the user to better analyze and interpret the daily data.  Module 1 is central to all departments because the knowledge of this module is considered the foundation for more advance statistical training. Module 2: Statistical Process Control (SPC) is specialized and designed to meet the requirements for those who design, monitor, and control pharmaceutical processes.  It focuses on using systematic methodology to collect, analyze, and interpret process generated data in addition to constructing process limits.  Statistical process monitoring and control methods will be demonstrated using real pharmaceutical examples with the aid of specialized statistical process control software.  Process capability will be covered to provide efficient statistical methods to evaluate the performance of the process and implement procedure to improve productivity. Module 3:  Design of Experiments in Pharmaceutical Sciences is designed to meet the need Specialized Statistical Process Control Software will be used throughout the course to strengthen the interactive simulations of typical process monitoring and controls to build up confidence and practical understanding of using up-to-date software.