This month’s section meeting will cover two related topics:
1. Laney U-Chart. This is a great Quality tool for quality professionals across all industries! The Laney U-Chart is a tool to determine if your process is truly in or out of control – ideally suited to analyzing complaint data. The Laney U-Chart adds tools designed to eliminate false
alarms when monitoring processes. “Quality practitioners across all industries can be confident about detecting special-cause variation only when it truly exists,” says Michelle Paret, Minitab product marketing manager. Minitab worked directly with David Laney to incorporate the charts into this latest update to top statistical software http://www.minitab.com/company/news/news-basic.aspx?id=10086 FDA Regulations Relative to Statistics provides specific expectations as well as an FDA inspection tool: Checklist.
2. The FDA Regulations Relative to Statistics. The FDA has specific expectations when auditing a company relative to statistical practices. Learn what they are looking for. Warning letters relative to statistics are most commonly for trending of CAPA data and lack of valid statistical justifications, but can include numerous other areas. So, in order to prepare for your next inspection, understand the regulation to ensure compliance! A quality tool–checklist–will be provided to identify areas to address with a list of recommendations for each identified area.
Dr. Wayne Taylor is a leading expert in the application of Statistics in the pharmaceutical, medical device and diagnostics industries. Dr. Wayne Taylor is the founder and chairman of Taylor Enterprises, Inc.. where he is responsible for the development of the VarTran®, sampling plan analyzer and distribution analyzer software packages as well as providing consulting and training to the FDA regulated industries in Statistics. He is author of the books Optimization and Variation Reduction in Quality and Guide to Acceptance Sampling. He is a leading expert in acceptance sampling, process validation, trending and CAPA problem solving. Dr. Taylor has a Ph.D. in Statistics and is an accredited professional statistician. The VarTran software and Dr. Taylor’s course, Robust Tolerance Analysis, have rapidly become a key component of many companies DFSS (Design for Six Sigma) programs, including Honeywell, the Six Sigma Academy and others. He retired after 22 years with Baxter Healthcare Corporation where he was Director of Quality Technologies and responsible for Baxter’s Six Sigma program. He is a fellow of the American Society for Quality, a fellow at the Royal Statistical Society, and a member of the American Statistical Association. Dr. Taylor received his Ph.D. in Statistics from Purdue University.