The A to Zs of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems (FDA GXP Compliance -)

Venue: Renaissance Newark Airport Hotel

Location: Elizabeth, New Jersey, United States

Event Date/Time: May 24, 2012 End Date/Time: May 25, 2012
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In spite of purity, microorganisms can flourish within these systems and lead to undesirable contamination of facility processes and their products. Of all the individuals at the facility who should understand the microorganisms in water systems and how best to monitor and control and them, it should be the site’s microbiologists. Sadly, this is often not the case due to the lack of familiarity with biofilm and its impact on water system sampling, testing, sanitization, and routine maintenance.

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 don’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.


1000 Spring Street
New Jersey
United States