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2022 ISPE Annual Meeting & Expo

SES206b - Trending and Pattern Recognition - Contamination Control Strategy


Nov 1, 2022 1:45pm ‐ Nov 1, 2022 3:15pm


Description

This presentation will include a brief review of key regulations as they relate to the need to use the data collected for trending, process control, investigation and root cause analysis. The digitization is still in process, pharma industry due to the regulatory scrutiny are sometimes late adopters but the need to digitize is ever more important based on the evolution of the regulations encouraging trending and using data.

The discussion will cover the key contamination control processes including pharmaceutical water, HVAC, and gas monitoring, as well as environmental and personnel monitoring, also touching on cleaning validation and cleaning process monitoring. The talk will relate to the different trending tools, when they should be used, and what they mean. Examples of trends will be included in the presentation.

Speaker(s):

  • Susan Cleary, Director of Product Development, Novatek International

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