[Live Webinar] Prevent Failure by Designing your Cleanroom Monitoring System to meet cGMP
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In this webinar, Jason Kelly, VP of Services will cover the implementation of a Monitoring System (EMS) in the framework of cGMP.
Learn how to initiate an EMS project from start to finish starting off with a Risk Assessment and completing with a Performance Qualification and setting up Service Level Agreements to ensure your business continuity is paramount and downtimes are kept to a minimum. By partnering with the right EMS vendor, you can leverage from the right experience to ensure your EMS project and more important your EMS environmental data is meaningful and that data is secure and accurate. Understand how to get the most out of your EMS and the data it produces and how to follow an EMS process flow to Supercharge your Contamination Control Strategy.
During this webinar we will cover:
- Risk Based approach to EMS design
- What is GMP
- URS importance and Traceability Matrices
- What sensors connect to an EMS
- How do particle counters detect contamination
- The sizes of particles in your cleanroom
- ISO 21501 and particle counter accuracy
- EMS overview and redundancy
- EMS software interface
- EMS Process Flow - EMS design and Implementation
- 21CFR11 testing and compliance
Who Should Attend?
- You need to gain information on implementing an EMS for your company
- You need to develop a Contamination Control Strategy for aseptic manufacturing
- You are responsible for EMS data and report generation for batch release
- You perform QA of EMS data
- You are responsible for supervising product manufacturing
- You are part of Environmental Monitoring Plan execution team
- You are part of Validation Master Plan team
- You are a cleanroom consultant
- You want to meet GMP for Cleanroom monitoring
- Jason Kelly has spent over 25 years working in the Pharmaceutical and Semi-Conductor Cleanroom Industry managing and delivering major Evironmental Monitoring projects and developing test protocols for IQ/OQ and PQ.
- He has also set up multiple ISO 17025 Particle Counter facilities worldwide and has many years of technical experience with partle counter calibrations to ISO 21501 standards.
- Jason has also published many technical articles on Environmental Monitoring in Cleanrooms and Particle & Air sampling technologies and travels frequently as a guest subject matter presenter around the world.