Novatek is proud to continue to sponsor and present at this year’s PharmaED Aseptic Processing Summit.

Join Sheba Zaman, Novatek’s Head of Product Specialists and Training Services present on: Learn How to Trend & Analyze EM Data

This presentation will cover two areas critical to the Aseptic Processing space.

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 nonconformances.

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

Full Program & Agenda can be found here: https://www.pharmaedresources.com/brochures/AsepticProcessingSummit2020.pdf