2-day In-person Seminar on
Statistics for the Non-Statistician RAPS Approved. Earn 12 RAC Points
Date & Time:
May 24th and May 25th 2012
9 AM PDT to 5 PM PDT
Duration: 2 Days
Instructor: Steven Walfish
Register Now
Instructor Profile:
Location: Courtyard by Marriott Washington, DC
Price : $1695.00
(for one participant)
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
Steven Walfish President, Statistical Outsourcing Services Mr. 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. ...more
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Areas Covered in the Session: Day 1, May 24th, 2012 Lecture 1: Introduction and Basic Overview of Common Statistical Tools l
Types of Data ¡
Continuous versus discrete
Descriptive versus inferential Data Presentation and Graphics ¡
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Normal Distribution Introduction to Hypothesis Testing ¡
P-value
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z-test t-test
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Chi-square
F-test Discuss applicable software packages for use: ¡
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Microsoft Excel - SAS
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Mini-tab - JMP
Lecture 2: Apply Statistics to Specification Setting l
Setting appropriate product specifications
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Determine FDA requirements for OOS results Determine how to best investigate OOS results
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Introduction to Interval Estimation ¡ ¡
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Confidence Interval Tolerance Interval
Outlier Analysis
Lecture 3: Regression analysis and variance components l l
Correlation Linear models
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Residual analysis Lack of fit
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Hazards of regression
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Multiple regression Non-linear regression (4-parameter models)
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Analysis of stability data including shelf life estimation
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Lecture 4: Implement Design of Experiments (DOE) l l l l
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 l l l
Analyze ICH guidelines (Q2A & Q2B) Ensure robustness and ruggedness of your method Develop protocols based on sound statistical methods
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Quantify validation characteristics: ¡ linearity - range ¡ accuracy - limit of detection (LOD) ¡ precision - limit of quantitation (LOQ)
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Regression analysis and variance components Analysis of Stability data.
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Lecture 6: Trending Analysis l l l l l
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)
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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
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requirements Process Analytical Technology
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Lecture 7: Design a Statistically Sound Sampling Plan l
Define different types of sampling ¡ random stratified composite Create and justify your sampling plan Account for sampling and measurement error ¡ ¡
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Determine the relationship between sample size, statistical precision, and statistical power
Lecture 8: Statistically Analyze Annual Product Review (APR) Data l
Examine statistical techniques relevant to APRs
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Use descriptive statistics to present the data Use graphs and plots effectively Interpret statistical data to identify trends and deviations
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Click here to register for this webinar 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: l
Directors
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Development Scientists
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Analytical Method Development QA/ QC personnel
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It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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