Course "Applied Statistics for Scientists and Engineers" has been pre-approved by

RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

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.

Why should you attend:

21 CFR and guidance documents for the pharmaceutical, biopharmaceutical, and medical device industries specify the application of statistical methods across the product quality lifecycle.

According to the Quality System Regulation (QSR) for medical devices, "Where appropriate, each manufacturer shall establish and maintain procedures for identifying valid statistical techniques required for establishing, controlling, verifying the acceptability of process capability and product characteristics." Although there are many statistical method that may be applied to satisfy this portion of the QSR, there are some commonly accepted methods that all companies can and should be using to develop acceptance criteria, to ensure accurate and precise measurement systems, to fully characterize manufacturing processes, to monitor and control process results and to select an appropriate number of samples.

According to both 21 CFR and guidance documents, the need for statistical methods is well established from discovery through product discontinuation. 21 CFR specifies the "the application of suitable statistical procedures" to establish both in-process and final specifications. The guidance documents necessitate the application of statistical methods for development and validation of measurement systems, process understanding using Quality by Design (QbD) principles, process validation, as well as ensuring the manufacturing process is in control and is capable.

This course provides instruction statistical methods for data analysis of applications related to the pharmaceutical, biopharmaceutical, and medical device industries.

Areas Covered in the Session:

Objectives:

·describe and analyze the distribution of data

·develop summary statistics

·generate and analyze statistical intervals and hypothesis tests to make data-driven decisions

·describe the relationship between and among two or more factors or responses

·understand issues related to sampling and calculate appropriate sample sizes

·use statistical intervals to setting specifications/develop acceptance criteria

·use Measurement Systems Analysis (MSA) to estimate variance associated with: repeatability, intermediate precision, and reproducibility

·ensure your process is in (statistical) control and capable

Who Will Benefit:

This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:

·Process Scientist/Engineer

·Design Engineer

·Product Development Engineer

·Regulatory/Compliance Professional

·Design Controls Engineer

·Six Sigma Green Belt

·Six Sigma Black Belt

·Continuous Improvement Manager

Agenda:

Day 1 Schedule

Lecture 1:

Basic Statistics

• sample versus population
• descriptive statistics
• describing a distribution of values

Lecture 2:

Intervals

• confidence intervals
• prediction intervals
• tolerance intervals

Lecture 3:

Hypothesis Testing

• introducing hypothesis testing
• performing means tests
• performing normality tests and making non-normal data normal

Lecture 4:

ANOVA

• defining analysis of variance and other terminology
• discussing assumptions and interpretation
• interpreting hypothesis statements for ANOVA
• performing one-way ANOVA
• performing two-way ANOVA

Day 2 Schedule

Lecture 1:

Regression and ANCOVA

• producing scatterplots and performing correlation
• performing simple linear regression
• performing multiple linear regression
• performing ANCOVA
• using model diagnostics

Lecture 2:

Applied Statistics

• setting specifications
• Measurement Systems Analysis (MSA) for assays
• stability analysis
• introduction to design of experiments (DOE)
• process control and capability
• presenting results

Speaker:

Richard (Rick) K. Burdick

Richard (Rick) K. Burdick is an Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc. for 10 years. He taught at ASU for 29 years at all levels including undergraduate business students, MBAs, Master of Statistics students, and doctoral candidates in both business and engineering. He received numerous teaching awards and taught a variety of courses for adult learners. His research and consulting interests consider several CMC statistical applications including comparability studies, stability data analysis, analytical method validation, quality by design process characterization, and analytical similarity for biosimilar products. He has written over 60 journal articles and three books, including Confidence Intervals for Random and Mixed ANOVA Models with Applications to Gauge R&R Studies, (with C. M. Borror and D. C. Montgomery) and Confidence Intervals on Variance Components, (with F. A. Graybill). Burdick is a Fellow of the American Statistical Association and a member of the American Society for Quality. He has served on the USP Statistics Expert Committee since 2010. He received his Bachelor's Degree in Statistics from the University of Wyoming. He received his Masters and Doctorate degrees in Statistics from Texas A&M University.

Location: Baltimore, MD Date: September 21st & 22nd, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The DoubleTree Baltimore-BWI Airport 890 Elkridge Landing Road - Linthicum, MD 21090

Price:

Register now and save $200. (Early Bird)

Price: $1,295.00 (Seminar Fee for One Delegate)

Until August 10, Early Bird Price: $1,295.00 From August 11 to September 16, Regular Price: $1,495.00

Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*

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