Live Pharma/Biopharma Contamination Control Strategies Event Scheduled For May 20th
Source: Particle Measuring Systems
Particle Measuring Systems is organizing a special event, to answer your questions related to your contamination control strategy:
To monitor your viable and non-viable particles count you must first identify the best approach.
Then report, document and manage the data collected.
You must do this all while meeting the most recent regulatory requirements (including Annex 1 and 21 CFR Part 11) and satisfying your process needs.
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