Overview on requirements and guidelines on EM data analysis
Considerations for EM data analysis using computerized system versus manual systems including speed of analysis, accuracy, volume of data
Routine Environmental Monitoring Reporting for State of Control including Recovery Rate Reports, Control Charts, Continuous Monitoring Trends, Microorganism Trends and Linear Regression by sampling sites o Review of method for trending o Frequency of trending o Data parameters used o Filtering and grouping data
Understanding the meaning of EM data trends including risk identification, pattern recognition, actions required, and conclusions
webcam xxx,Part 2: Trending for Root Cause Analysis
Non-Routine data analysis for assisting in investigations including o Assessing root cause and assessment of impact to product including comparison of personnel, equipment, product sampling sites, media, microorganisms, occupant count, proximity to process/product. o Setting appropriate alert measures required for maintaining a state of control based on data including pattern recognition (rolling specifications), adverse trends, and non-conformances.
Using EM data analysis as part of a continuous improvement to EM program improvements
The transition from a paper base system to an automation solution.