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

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Category seminar Washington DC,Statistics for the Non-Statistician,Hypothesis Testing,Excel - SAS,FDA requirements,OOS results,Regression analysis,Design of Experiments,Validate Testing Methods,Trending Analysis,Sampling Plan,Annual Product Review

Deadline: May 24, 2012 | Date: May 24, 2012-May 25, 2012

Venue/Country: Courtyard by Marriott Washington DC , 8 AM to 5 PM, U.S.A

Updated: 2012-03-14 19:42:12 (GMT+9)

Call For Papers - CFP

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: supportglobalcompliancepanel.com

http://www.globalcompliancepanel.com

Price: $1,495.00

GlobalCompliancePanel

1000 N West Street, Suite 1200,

Wilmington, DE 19801, USA