2014 - "Data Analysis in QSR"

DESCRIPTION
Have you implemented the data analysis requirements in QSR? If not, you could be wasting money on missed improvements. You also run the risk of an FDA Warning Letter from your next inspection. This webinar gives you the tools and techniques to implement an effective data analysis program.
Device manufacturers often don’t recognize the requirement in 820.100(a)(1) to analyze quality data to identify quality problems. Consequently, there may be unrecognized quality problems. For example, in one company a Warning Letter says that 36 of 210 complaints were for the shipping the wrong product. The company had not identified the problem, investigated it, or taken corrective action. The FDA Investigator uncovered the issue. Similarly, a company could have costly and unrecognized problems with nonconforming product.