2012 - Statistics for the Non-Statistician - US Seminar 2012 at Washington DC

Overview: This course will help you to use statistics correctly and minimize compliance risk.
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 product to the market that ultimately fails eventually 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 begins by the 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. Addressed is 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 and 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.
Areas Covered in the Session:
Day 1, May 24th, 2012
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
Lecture 3: Regression analysis and variance components
Correlation
Linear models
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
Day 2, May 25th, 2012
Lecture 5: 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.
Lecture 6: 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
Lecture 7: 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
Lecture 8: 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
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
QA/ QC personnel
Contact Information:
Event Coordinator
Toll free: 800-425-9409
Fax: 302-288-6884
Email: support-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA