Statistics for Non-Statisticians Seminar
Presented by Global Compliance Panel
This seminar will be highly interactive and participative. Participants apply their learning of statistics to real-world example data sets. The program begins by providing a basic overview of the most common statistical tools and terms. Course DescriptionStatistical tools and techniques are very commonly used to help measure and improve the quality of a firm's process and product. If statistical analysis is not properly performed and/or understood, a firm can run the risk of distributing the kind of product to the market that ultimately fails, resulting in lost time and money. And of course, with statistics, practice makes perfect. During this two-day HIGHLY interactive training program, participants will be given the opportunity to apply statistics learned to real-world example data sets! The program begins by providing a basic overview of the most common statistical tools and terms. The course covers the use of statistical software packages and the role of software in statistical analysis and statistical process control. Areas addressed include how to use statistics to properly trend data, support the annual product review, justify process changes and set product specifications. By the end of day two, course participants will have acquired the skills necessary to design a statistically sound sampling plan that helps them comply with FDA APR requirements. Throughout the duration of this intimate, hands-on course, participants will be able to interact with both an expert instructor and their peers. Why should you attend:This course will help you to use statistics correctly and minimize compliance risk. Who will benefit:
Day 1 Schedule: Lecture 1: Introduction and Basic Overview of Common Statistical Tools Exercise: Identify Participants' Statistical Experience and Course Goals
Lecture 2: Apply Statistics to Specification Setting
Exercise: Setting Statistical Based Specifications Lecture 3: Regression analysis and variance components
Lecture 4: Implement Design of Experiments (DOE)
Exercise: Mock Experimental Design Day 2 Schedule: Lecture 1: Validate your Testing Methods using Statistics
Exercise: Analysis of a Method Validation Study Including Protocol Development Lecture 2: Trending Analysis
Exercise: Review and Critique a Sample SPC Control Chart Lecture 3: Design a Statistically Sound Sampling Plan
Exercise: Create a Mock Sampling Plan Lecture 4: Statistically Analyze Annual Product Review (APR) Data
Exercise: Apply Learned Statistical Techniques to Real-World Data Discussion: Wrap-up Question and Answer Session Instructors Profile: Steven WalfishPresident, Statistical Outsourcing ServicesMr. Steven Walfish brings is the founder and President of Statistical Outsourcing Services. He brings nearly 20 years of industrial experience providing statistical solutions to complex business problems. Mr. Walfish was Senior Manager Biostatistics, Nonclinical at Human Genome Sciences in Rockville MD. Mr. Walfish has held positions with PricewaterhouseCoopers, Chiron Diagnostics and Johnson & Johnson. Mr. Walfish holds a Bachelors of Arts in Statistics from the University of Buffalo, Masters of Science in Statistics from Rutgers University and an Executive MBA from Boston University.
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