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 conclusion

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 conformances.
• Using EM data analysis as part of a continuous improvement to EM program improvements

About the Presenter

Sheba Zaman
Novatek International

Sheba Zaman has been serving in a technical role at Novatek International for over 18 years. With university degrees in both Health Science and Computer Science, she is an expert in the data management and analysis of critical pharmaceutical computer systems such as Environmental Monitoring, Utility Monitoring, Cleaning Validation, LIMS, Stability and Quality Management Systems. Currently Head of Product Specialists and Training Services, she is experienced in helping companies manage and analyze their analytical data. She has worked with clients globally for over a decade managing change and implementation of software solutions, including establishing procedures, work instructions, validation scripts and training programs. Key areas of expertise include Data Integrity, Process Improvement, FDA compliance and Software Implementation and Optimization in a regulated environment. She also serves as a President-Elect for the PDA Southern California Chapter.