The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: July 16, 2015 at 9am to July 17, 2015 at 6pm
Location: Zurich, Switzerland
Street: Zurich, Switzerland
City/Town: Zurich, Switzerland
Website or Map: https://www.globalcompliancep…
Event Type: clinical, food, fda, medical, device, defence, and, navy, aerospace, mining
Organized By: GlobalCompliancePanel
Latest Activity: Apr 22, 2015
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.
Who Will Benefit:
This seminar is designed for pharmaceutical, biopharmaceutical, and medical device professionals who are involved with product and/or process design:
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.