Combining Particle & Microbial Sensors to Meet Regulatory Requirements
Sponsored by: Particle Measuring Systems
- Particle Sensors
- Microbial Sensors
- E U G M P Annex 1
- I S O 14644 1 And 2
Date: 22 November
Time: 3PM London/10AM New York
Attend this webinar to learn how to meet regulatory contamination monitoring requirements for your cleanroom.
Particle contamination is a mixture of nonviable and viable particles. Historically, nonviable particles are monitored continuously while viable particles have been monitored on a less frequent basis. In current aseptic manufacturing, both types must be monitored continuously to obtain an accurate indication of the cleanroom's condition.
An effective monitoring program provides the required data and ensures data integrity through the use of an automated system to track any changes. The system used to track and record data must meet the requirements of 21 CFR Part 11 and must be used.
Global Product Line Manager Systems and Software
Paul Hartigan is the Global Product Line Manager for Software and Systems with Particle Measuring Systems. He has held various product management responsibilities over the last 10 years with Particle Measuring Systems including responsibility for Liquids, Aerosol and Microbial based products, with his latest role being involved in the Environmental Monitoring Systems.
Key Learning Objectives
- Learn how to effectively implement key regulations related to an Environmental Monitoring Systems
- Learn how to properly incorporate both particle and microbial sensors into a unified system
- Understand which data and reports can be used to make strategic changes and identify potential problems
- Quality Control
- Operations Personnel
- Operations Supervisor
- Manufacturing Personnel