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Mastering Environmental Monitoring

: 15 Oct 2019 - 16 Oct 2019

: Wattwil, Switzerland

Sector: Pharmaceutical

Type: Training


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 CAS to see calibration of devices in action.

 

Theory sessions will cover the following topics:

  • Monitoring particles in air, Cleanroom classes and classification, Principles of ISO 14644 1 and 2
  • Microbiological classification & monitoring of air, surfaces & personnel - Theory - Methods, Examples of devices
  • Regulations and guidelines - GMP & EP/USP
  • Brief inside on EU GMP New Annex 1 with focus on EM
  • Deviations / investigations, Data trending, Data integrity

Hands-on sessions will feature:

  • Realtime EM, Gowning exercise, contact plates surfaces / personnel
  • Devices, software demonstration • Calibration lab: Calibration of devices, wind tunnel

Workshop will allow delegates to discuss:

  • Risk analysis, Design of EM, Discussion of workshop results
  • Case studies - Discussion of findings on aseptic handling, data integrity, data trending for EM 

Find out more / register here:

Venue

Wattwil
Switzerland


<< Previous article
WMFmeetsIUPAC Mycoto...
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Failure Investigatio...