Statistics for the Non-Statistician Seminar

Course "Statistics for the Non-Statistician" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

Statistical 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:

This course is developed to provide valuable assistance to all regulated companies that need to understand their processes including companies: 

• Medical Device
• Diagnostic
• Supervisors
• Pharmaceutical
• Biologics fields

Agenda:

Day 1 Schedule

Lecture 1:

Introduction and Basic Overview of Common Statistical Tools

Types of Data

• Continuous versus discrete
• Descriptive versus inferential
• Data Presentation and Graphics
• Normal Distribution
• Introduction to Hypothesis Testing
  • P-value
  • z-test
  • t-test
  • Chi-square
  • F-test
• Discuss applicable software packages for use:
  • Microsoft Excel - SAS
  • Mini-tab - JMP

Lecture 2:

Apply Statistics to Specification Setting

• Setting appropriate product specifications
• Determine FDA requirements for OOS results
• Determine how to best investigate OOS results
• Introduction to Interval Estimation
• Confidence Interval
• Tolerance Interval

Outlier Analysis

Exercise: Setting Statistical Based Specifications

Lecture 3:

Regression analysis and variance components

• Correlation
• Linear models
• New Patient Rights
• Residual analysis
• Lack of fit
• Hazards of regression
• Multiple regression
• Non-linear regression (4-parameter models)
• Analysis of stability data including shelf life estimation

Lecture 4:

Implement Design of Experiments (DOE)

• Design experiments appropriately and effectively
• Ensure that experiments are reproducible
• Improve process capability by reducing variability
• Analysis of variance

Exercise: Mock Experimental Design

Day 2 Schedule

Lecture 1:

Validate your Testing Methods using Statistics

• Analyze ICH guidelines (Q2A & Q2B)
• Ensure robustness and ruggedness of your method
• Develop protocols based on sound statistical methods
• Quantify validation characteristics:
• linearity - range
• accuracy - limit of detection (LOD)
• precision - limit of quantitation (LOQ)

Regression analysis and variance components Analysis of Stability data.

Exercise: Analysis of a Method Validation Study Including Protocol Development

Lecture 2:

Trending Analysis

• Define Statistical Process Control (SPC)
• Determine how SPC can be applied to and help your process
• Identify the benefits of using SPC
• Trend Analysis
• Comply with FDA Requirements for Process Analytical Technology (PAT)
• Define Process analytical technologies and identify related tools
• Identify the role statistics play in the PAT framework
• Comply with the FDA's 2004 PAT draft guidance requirements
• Process Analytical Technology

Exercise: Review and Critique a Sample SPC Control Chart

Lecture 3:

Design a Statistically Sound Sampling Plan

• Define different types of sampling
• random
• stratified
• composite

Create and justify your sampling plan Account for sampling and measurement error Determine the relationship between sample size, statistical precision, and statistical power

Exercise: Create a Mock Sampling Plan

Lecture 4:

Statistically Analyze Annual Product Review (APR) Data

• Examine statistical techniques relevant to APRs
• Use descriptive statistics to present the data
• Use graphs and plots effectively
• Interpret statistical data to identify trends and deviations

Exercise: Apply Learned Statistical Techniques to Real-World Data

Discussion: Wrap-up Question and Answer Session

Quick Contact:

NetZealous DBA as GlobalCompliancePanel 

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link -   http://bit.ly/29u0BEa-Statistics

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