At 12pm Wednesday, February 19th, Jason Kelly, Vice President of Services, Lighthouse Worldwide Solutions will be presenting on the topic of "Environmental Monitoring System Design – to meet cGMP"
SESSION DESCRIPTION
- With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21CFR11 in the context of GAMP 5 requirements.
- How a Company creates, maintains, retrieves, corrects and controls data can affect product quality. How a company reacts to out of tolerance conditions via continuous Environmental Monitoring Systems (EMS) alarm notification is crucial to the process operation and the product quality.
- Therefore the EMS becomes a critical process tool to ensure product quality and the supporting data.
Topics Covered
- Particle Counter Detection technology
- ISO 21501-4 Particle Counter calibration
- Risk Mitigation
- How to Develop the Risk Assessment
- What type of sensors
- EMS Overview
- EMS Process flow
- Validation
- 21CFR11 Compliance
- PQ and Change Control
- Setting Alarm Limits
- Data Integrity
Takeaway Tools
- Free Webinar event for March
- Template Monitoring System design overview
- EMS Process workflow chart
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