Environmental Monitoring - Trending, Analysis and Data Management - Live Online Training

Regulatory agencies require from manufacturing companies of pharmaceuticals and biopharmaceuticals, particularly of sterile drug products, to maintain an environmental monitoring program, whereby particulates as well as microorganisms in either air samples (active and passive sampling) or in surfaces (contact plates) 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 following challenge for the responsible person in quality is charting, analyzing data, setting action and alert limits, interpreting the overall monitoring process behaviour, detecting a trend or shift in contamination levels, monitoring excursion rates and contamination recovery rates, while conducting an ongoing risk analysis. According to the recent revision of EU Annex 1 (Draft 2020/2021), results from monitoring should be considered when reviewing batch documentation for finished product release. Therefore, this course is aimed at providing empirical tools for charting and trending EM data.

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