Designing a Facility Monitoring System (FMS) to control and report on contamination related to your Pharmaceutical Production requires careful analysis before making impactful decisions.
You need to identify the best approach to monitor your viable and non-viable particles, count, report, document and manage your environmental monitoring data meeting the most recent
regulatory requirements, including Annex 1 and 21 CFR Part 11, all while meeting your process needs.
Particle Measuring Systems is organizing a special event, dedicated to Scandinavia, to answer your questions related to effective cleanroom monitoring.
Our Panel of Experts will present answers to questions submitted on these topics:
- Standards, guidelines and best practices
- Annex 1 upcoming changes
- ISO 14644-1/2
- 21 CFR Part 11
- Designing a Facility Monitoring System (FMS)
- Location of sample points
- System installation and sampling tubing
- Selecting a particle counter
- Microbial Monitoring
- Preparing for and anticipating questions from inspectors
- Continuous microbial monitoring
- Data Management
- Data trend analysis
- Alerts and alarms definition and setting
- Instrument calibration
- Differences between standards and ISO 17025 calibration
To join this live event, simply complete the form by 17th March, including your questions.
Note: we keep confidential the names/ company related to each question. Your name is not shown to other event attendees.
Panel of Cleanroom Contamination Control Experts
|Bjarke Adrian Madsen – Nordic Sales Manager|
|Daniele Pandolfi – Global Product Line Manager, Systems, Software & Services|
|Giulia Artalli – Global Product Line Manager, Micro & Sterility|
|Maurizio Della Pietra – Associated Product Line Manager for LS Service|
For any info please Contact Us!