SPEAKER VIRTUAL CONFERENCE: PharmaED Aseptic Processing Virtual Summit 2020

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