21CFR, Part 820.210 Corrective and Preventive Action requires appropriate statistical methodology shall be employed where necessary to detect recurring quality problems. Learn how to set up a trending plan to insure the application of valid statistical techniques to the trending of quality data including customer complaints (like MDRs and AEs), production data and repair data. Provides a review of the trending tools, describes how to select the right trending tool and covers topics such as normalizing data, frequency to update the chart, how to divide or group charts and the frequency and documentation of reviews.

Wednesday, June 9, 2010
Session 301: Trending Quality Data

Instructor: Wayne Taylor, PhD, Chairman, Taylor Enterprises, Inc.