Seminar on Applied Statistics for Scientists and Engineers at Boston, MA

Event Details

Time: August 20, 2015 at 9am to August 21, 2015 at 6pm
Location: Courtyard Boston Logan Airport
Street: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA
City/Town: Boston
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Apr 27, 2015

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Event Description

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.

Why you should 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."

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

Speaker:

Dr. Heath Rushing, is the cofounder of Adsurgo and author of the book Design and Analysis of Experiments by Douglas Montgomery: A Supplement for using JMP. Previously, he was the JMP and Six Sigma training manager at SAS. He led a team of nine technical professionals designing and delivering applied statistics and quality continuing education courses.

Location: Boston, MA Date: August 20th & 21st, 2015 Time: 9:00 AM to 6:00 PM