Environmental Monitoring Data Management – From Collecting to Trending
: 20 Nov 2019 - 21 Nov 2019
: Barcelona, Spain
Regulatory agencies require that manufacturers of pharmaceuticals and biopharmaceuticals, particularly of sterile drug products, maintain an environmental monitoring program, whereby particulates as well as microorganisms in either air samples or on surfaces are routinely tested and monitored.
Thus, a multitude of environmental microbial data is generated on a routine basis and it is recorded in a manner permitting trend evaluation. But collecting EM data is only the first challenge. The next challenge, for the responsible person, in quality is charting, analyzing data, setting action and alert limits, interpreting the overall monitoring process behavior, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis.
This course is aimed at providing empirical tools for charting and trending EM data.
- Introduction to charting and trending
- Regulations on environmental monitoring
- Variability of data
- Control charts of grouped data
- Brief acquaintance with Minitab 17
- Control charts of individual microbial counts
- Data strategies and environmental monitoring – MODA System
- Environmental monitoring program to gain strong data
- Contamination recovery rates
- Distribution-free approach
- Trending tool applications
- General approach to microbial monitoring
- Investigation and risk assessment
- Strategy for detecting a trend and for continuous improvement