Lighthouse Worldwide Solutions Director of Systems - Jason Kelly presented at ISPE Canada event
Lighthouse Worldwide Solutions Director of Systems – Jason Kelly presented at International Society of Pharmaceutical Engineers (ISPE) OPERATIONAL EXCELLENCE IN THE CANADIAN MANUFACTURING LANDSCAPE on October 24th in Canada.
His presentation covered the key parts of designing, implementing and maintaining a real time environmental monitoring system. Jason reviewed the pros and cons of wired vs wireless systems, identifying sampling locations through risk assessment. He also provided an overview of industry regulations and guidelines output by the FDA and EU GMP for monitoring of cleanroom environments. Jason has over 20 years Industry Experience in Controlled Environments and Environmental Monitoring Systems spanning across Europe, Australia, Asia and the USA.
If you have a Controlled Environment or Cleanroom and manufacture aseptic products and are considering an Environmental Monitoring System or Particle Monitoring System, this presentation provides up to date and accurate informative information on the GAMP process from Risk Assessment to User Requirement Specification development and the V-Model GAMP process for Validation. The presentation includes a review of System design, Probe Placement, Sensor Technology, System Networks, EUGMP Annex 11 Computerized Systems, current Regulatory Compliance, 21CFR11 and Data Integrity. It also provides an overview of installed systems with a focus on Risk Mitigation and Risk Management based on ICHQ9 and Annex 20 Guidelines.
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