The A to Zs of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems (FDA GXP Compliance -)
|Event Date/Time: May 24, 2012||End Date/Time: May 25, 2012|
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not a requirement. The instructor can provide the necessary background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system control consists of a set of rules that often donâ€™t work and can cause very costly system downtime or even product recalls.
Learning Objectives :
At the completion of the course, attendees will be able to:
- Understand the role of system design, maintenance and sanitization in controlling microbial levels in pharmaceutical water systems.
- Successfully troubleshoot problems resulting from poor design/maintenance versus sampling or testing problems.
- Devise water system validation protocols that truly validate microbial control.
- Validate your water microbial test method.
- Develop sound Alert and Action Levels and Water Specifications.
- Defend your test method, in-process control levels and specifications to FDA.