Both European and American GMP regulations place special focus on this topic. Therefore, it is the aim of this course to provide the participants with pragmatic recommendations for the creation and implementation of environmental monitoring programmes. This Education Course is directed at staff from Production, Quality Assurance and Quality Control who is responsible for the planning and implementation of environmental monitoring programmes Environmental Monitoring. Why do we do it . Which one(s) should I follow? The objective of this session is to review the key points of the guidelines and to apply a common sense approach to their application to your facility and processes.
Non- viable (particulate) Air Monitoring Surface / Personnel Monitoring The question of validating recovery has often been raised but it is a question of trying to validate the impossible. Personnel are without doubt the major source of contamination in a clean room environment and are therefore the major hazard to aseptic process. Personnel monitoring is obviously of value in assessing contamination risks. The questions in personnel monitoring are basically when and how? Role of Environmental Monitoring and Microbiological Testing During Manufacture of Sterile Drugs and Biologics*. The Novatek Environmental Monitoring Software Solution, Nova-EM, is an industry proven standard with over 15 years of industry use, for managing controlled environments. Trending in the EM Program by Scott Sutton 6. Best Practices in Environmental Monitoring Automation by Robert Toal. There is the potential that the monitoring interventions do more harm than good and the results generated are valueless for risk assessment purposes but are very useful for pressurising QA personnel. The intention in this session is how to achieve results of real value from your surface and personnel monitoring programme. Case Study: Microbiological Methods Clean Rooms . RABS (Restricted Access Barrier Systems) and isolators represent the state of the art. Which consequences arise for environmental monitoring? Environmental Monitoring for Non- Steriles Cover potential benefits against the cost, discuss regulatory view- point, and provide a case study. Deviation Management for Environmental Monitoring Investigations / Documentation
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