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).
Attend this webinar to learn:
- Critical microbial data management – Interpretations, considerations and solutions for data integrity, statistical control and FDA guidelines.
- FDA and ICH guidelines and recommendations – How to leverage this information for better contamination control.
- Data integrity – Definition and Inspectors’ perspective regarding environmental monitoring and data management, with attention to 21CFR Part 11.
- Elements to consider to ensure that a process is under statistical control.
- The future of microbial monitoring in the Pharma industry – Benefits of single use microbial monitoring.
This presentation is offered at multiple times to suit various time zones. Please pick the session that is best for you: