Course Description:

Course "2-day In-person Seminar: Introduction to Design of Experiments for Process Characterization" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

This course is designed to help scientists and engineers understand the statistical methods used in characterization of a process. Variability is part of every process, design of experiments helps to separate systematic variability from special cause variability.

You will get a chance to examine the different sources of variability how it relates to analytical method development, process improvement and sample size selection. The concept of experimental budget will be introduced to help you plan the total number of experiments needed. You will also learn to improve process output characteristics including quality, cost, and robustness through generating empirical models of your processes in the fewest experiments possible.

This highly interactive course will allow participants the opportunity to develop strategies for analysis of experimental data.The objective is to provide participants with key technical information along with perspectives to enable them to apply the technologies to their own projects and evolve their own statistical methods to support the various stages of product development.

Learning Objectives:

  • Learn the technical details and rationale for selecting and analyzing well designed statistically based experiments.
  • Develop the confidence to design and execute experiments that maximizes information in your day-to-day activities.
  • Participate in discussions with other course attendees to increase your confidence and proficiency in statistical hypothesis testing.
  • Determine the most robust settings in your process to minimize the different sources of variability.

Who will Benefit:

This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include: development scientists, analytical method development, and QA/ QC personnel

Course Agenda/Areas Covered:

  • Introduction to Statistical Hypothesis Testing.
    • Null hypothesis versus the alternative.
    • Different errors that can be made in doing statistical tests.
    • When do we use the Z-test and when do we use the t-test.
    • Testing variances.
  • Overview of Analysis of Variance and Variance Components.
    • Fixed versus Random Effects.
    • What does a p-value mean and how do I interpret them?
    • Understanding an ANOVA table.
    • How do I use ANOVA to calculate variance?
  • Fractional Factorial Designs including Plackett Burman.
    • Screening experiments.
    • Resolution of a design
    • What is an interaction?
    • Building an appropriate model.
  • Three level designs including Box-Behnken.
    • How do I test if there is curvature in my response?
    • How are three factor models different than center points?
  • Response Surface Designs.
    • Building a predictive model.
    • Using contour plots to find the optimums.
  • Response Desirability for Multiple Responses.
    • Balancing multiple responses for the same experiment.
    • Find the best sub-optimal region.

Meet Your Instructor

Steven Walfish
President of Statistical Outsourcing Services

Steven Walfish , is the President of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to FDA regulated industries. Prior to starting Statistical Outsourcing Services, Mr. Walfish was the Senior Manager Biostatistics, Non-clinical at Human Genome Sciences in Rockville MD. Prior to joining HGS, Mr. Walfish was a Senior Associate at PricewaterhouseCoopers specializing in the pharmaceutical industry.Mr. Walfish was Manager of Non-Clinical Statistics at Chiron Diagnostics.

Mr. Walfish brings over 20 years of industrial expertise in the development and application of statistical methods for solving complex business issues including data collection, analysis and reporting.

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Very informative and useful. Information I can actually use here at work, Thank You Mr. Walfish!
- RABQSA CMS Auditor, Diagnostica Stago, Inc

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