The VP of Services, Lighthouse Worldwide Solutions, Jason Kelly to host the webinar covering the implementation of a Monitoring System (EMS) in the framework of cGMP.
FREMONT, CA: Jason Kelly,VP of Services, Lighthouse Worldwide Solutions, will host a webinar on how to commence an EMS project from start to finish.This webinar will cover various topics from risk assessment before beginning a project toperformance qualification and setting up service level agreements to ensure business continuity and keep downtimes to a minimum. By collaborating with the right EMS vendor, organizations can leverage the right experience to secure the EMS project. More importantly, the EMS environmental data is valuable, and that data is safe and accurate. Understand how to extract most of the EMS and the data it produces and how to follow an EMS process flow to supercharge the Contamination Control Strategy.
During this webinar, Jason will cover:
• Risk-Based viewpoint to EMS design
• What is GMP
• URS significance and Traceability Matrices
• What sensors connect to an EMS
• How do particle counters discover contamination
• The sizes of particles in the cleanroom
• ISO 21501 and particle counter precision
• EMS overview and redundancy
• EMS software interface
• EMS Process Flow - EMS framework and Implementation
• 21CFR11 testing and compliance
Who Should Attend?
• One needs to gain information on implementing an EMS for their company
• They have to develop a Contamination Control Strategy for aseptic production
• Who is responsible for EMS data and report generation for batch release
• Who performs QA of EMS data
• Those responsible for supervising product manufacturing
• Who belongs to the Environmental Monitoring Plan execution team
• Who is part of the Validation Master Plan team
• Who is a cleanroom consultant
• Those who want to meet GMP for Cleanroom monitoring
Jason Kelly has over 25 years’ experience working in the pharmaceutical and semi-conductor cleanroom industry, taking responsibility for managing and delivering major environmental monitoring projects and developing test protocols for IQ/OQ and PQ. He is also known to have set up multiple ISO 17025 particle counter facilities worldwide and has many years of technical experience with particle counter calibrations to ISO 21501 standards.