The BioTech Pharma Summit will bring together the movers and shakers in pharma industry from several areas. Uniting niche and top buyers and sellers together under one roof in one event location.
Novatek is proud to be speaking during the Aseptic Processing Technology Session on:
Title: Learn How to Trend & Analyze Environmental Monitoring Data
By: Susan Cleary, Director of Product Development at Novatek International
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 o Review of method for trending o Frequency of trending o Data parameters used o 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 o 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. o 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
- The transition from a paper base system to an automation solution.
