Leveraging Microbial Contamination Monitoring Data For Actionable Insights To Meet And Exceed The Auditor's Expectations

Effectively monitoring microbial contamination in your cleanroom has become even more essential over the last year, especially with the upcoming release of EU GMP Annex 1. Modern pharmaceutical manufacturers are already generating and managing big data from environmental monitoring; the next step is to create actionable insights and ensure 21CFR11 compliance. This webinar discusses data collection, 21CFR11 data management and the generation of actionable insights. We will review how this is accomplished by leveraging industry standards such as the FDA/ICH guidelines that encourage the use of control charts as statistical tools to guarantee that a manufacturing process remains in a state of control (the validated state).