Part 1: EM Trending Requirements

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: Review of method for trending, Frequency of trending, Data parameters used, Filtering and grouping data Understanding the meaning of EM data trends including risk identification, pattern recognition, actions required, and conclusions

Part 2: Trending for Root Cause Analysis

Non-Routine data analysis for assisting in investigations including: 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. Setting appropriate alert measures required for maintaining a state of control based on data including pattern recognition (rolling specifications), adverse trends, and non conformance. Using EM data analysis as part of a continuous improvement to EM program improvements

Speaker

Sheba Zaman has been serving in a technical role at Novatek International for over 18 years.With degrees in both Health Science and Computer Science, she is an expert in the management of critical pharmaceutical computer systems such as LIMS, Stability, Environmental Monitoring, Cleaning Validation and Quality Management Systems. Key areas of expertise include Data Integrity, Process Improvement, FDA compliance and Software Implementation and Optimization in a regulated environment. Sheba also serves as a trainer for the PDA (Parenteral Drug Association) and is currently President for the PDA Southern California Chapter.

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