The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products

Seminar- The A to Z's of Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals, Biologics, Medical Devices, Cosmetics, and Personal Care Products “on Wednesday & Thursday Sep 29 - Sep 30 ,2021 (8 Hrs.)

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All facilities manufacturing pharmaceuticals, biologics, medical devices, cosmetics, and personal care products are likely to have high purity water systems. In spite of this 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, it is site’s microbiologists who should understand the microorganisms in water systems and how best to monitor and control them. 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, since this training is for everyone involved with water systems, from the lab to utility room operations. The instructor will provide the necessary background needed to understand this very important subject matter.

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 their water microbial test method.
Develop sound Alert and Action Levels and Water Specifications.
Defend their test method, in-process control levels and specifications to FDA.