PDA Training Course: Mastering Environmental Monitoring
Date: 15 October 2019 - 16 October 2019
Particle Measuring Systems | CAS Clean-Air-Service AG
Environmental Monitoring (EM) is one of the key pillars to ensure aseptic manufacturing. It covers particle measurement and hygiene monitoring (air and surface sampling). This two-day course is set up as a highly interactive event with hands-on lab training sessions and workshop sessions on risk analysis and design of Environmental Monitoring. The lecture part will cover current regulations, methods and devices. All participants are invited to bring their own case studies or audit findings and questions to be discussed in the group. The group has the unique opportunity to visit the calibration lab of PMS/CAS to see calibration of devices in action.
Upon completion of this course the participants
- Have understood the principles of EM
- Can explain different methods of EM (microbial, particles), standard and advanced methods
- Have understood basic designs of EM program in facility or clean room
- Are able to give input to / perform a risk analysis
- Have understood impact of operator behaviour in cleanroom on EM
- Can operate EM devices
- Have understood principles of data trending and integrity
- Have understood current guidelines and regulations (including Annex 1 revision).