Seminar on Applied Statistics for Scientists and Engineers at Zurich
About This Event
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.
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." 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.
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. He created tailored courses, applications, and long-term training plans in quality and statistics across a variety of industries to include biotech, pharmaceutical, medical device, and chemical processing. Mr. Rushing has been an invited speaker on applicability of statistics for national and international conferences. As a Quality Engineer at Amgen, he championed statistical principles in every business unit. He designed and delivered a DOE course that immediately became the company standard required at multiple sites.
Location: Zurich, Switzerland Date: July 16th & 17th, 2015 Time: 9:00 AM to 6:00 PM
Venue: WILL BE ANNOUNCED SOON
Price: $2,095.00 (Seminar for One Delegate)
Register now and save $200. (Early Bird)
Until June 10, Early Bird Price: $2,095.00
From June 11 to July 14, Regular Price: $2,295.00
Contact Information:
NetZealous LLC,
DBA GlobalCompliancePanel
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
USA Phone: 800-447-9407
Fax: 302-288-6884
[email protected]
http://www.globalcompliancepanel.com
Event Registration Link - http://bit.ly/1OwI6ew