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Strategic Partner

September 21, 2017 - September 22, 2017

Applied Statistics for Scientists and Engineers

The DoubleTree Baltimore-BWI Airport, Baltimore, MD

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Event Details

Begins: September 21, 2017

End: September 22, 2017

Event Location: The DoubleTree Baltimore-BWI Airport, Baltimore, MD

Website: http://www.globalc..46SEMINAR

Event Organizer

Event Organizer: Global Compliance Panel

Contact Person:

Phone Number: +1-800-447-9407

Website: https://www.globalcompliancepanel.com/

Overview

Throughout 21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries, the application of statistical methods are specified for: setting validation criteria and specifications, performing measurement systems analysis (MSA), conducting stability analysis, using design of experiment (DOE) for process development and validation, developing process control charts, and determining process capability indices.

Different statistical methods are required for each of these particular applications. Data and tolerance intervals are common tools used for setting acceptance criteria and specifications. Simple linear regression and analysis-of-covariance (ANCOVA) are used for setting expiries and conducting stability analysis studies. Two-sample hypothesis tests, analysis-of-variance (ANOVA), regression, and ANCOVA are methods used for analyzing designed experiment for process development and validation studies. Descriptive statistics (distribution, summary statistics), run charts, and probability (distributions) are used for developing process control charts and developing process capability indices.

This course provides instruction on how to apply the appropriate statistical approaches: descriptive statistics, data intervals, hypothesis testing, ANOVA, regression, ANCOVA, and model building. Once competence in each of these areas is established, industry-specific applications are presented for the participants.

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