2001 Post Oak Boulevard
Houston, TX 77056
8:00 a.m. Wednesday, April 17, 2013
The FDA's Quality System Regulation (QSR) requires device manufacturers to identify valid statistical techniques to "establish, control, and verify the acceptability of process capability and product characteristics." Some manufacturers are not clear about what this means, while others employ statistical techniques but remain nervous about this means.
Similarly, sampling plans must be valid, documented, adequate, and reviewed based on changes.
In addition, statistical methodology, as part of CA & PA, is required to identity recurring quality problems based on data system analysis. A similar requirement applies to servicing analysis.
In addition, the requirement for process validation with a "high degree of assurance" is a requirement for process capability and product characteristics, i.e., a statistical technique.
These four areas often create a patchwork of techniques without a coherent approach. This seminar will help you resolve the problem.
The seminar starts with an understanding of the regulations through a variety of sources. Each application of statistical techniques starts with the regulatory requirements and is augmented by the preamble, where FDA addressed the comments it received on the proposed QSR. FDA published an extensive manual to help manufacturers implement the regulations. The seminar analyzes the objectives in the Quality System Inspection Technique (QSIT) and then turns to Warning Letters to help understand the issues. $1699