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SPEAKER VIRTUAL CONFERENCE: PharmaED Aseptic Processing Virtual Summit 2020
September 21, 2020 @ 8:00 am - September 22, 2020 @ 5:00 pm
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