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All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems

 

Most pharmaceutical biofilms, especially those in water systems, suffer from one major flaw: misconceptions. Strict and rigid rules for design and operations, especially when they are built on ignorance, come in the way of proper implementation of effective water systems. When myths and hype surround these systems, it is but natural that they are doomed to failure.

Those in charge of pharmaceutical biofilms, more so those who deal with water systems need to be aware of all the aspects of water systems if they have to avoid failures. Lack of it can result in costly system downtime or even product recalls. It can result in costly system downtime or even product recalls.

All about Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems3

Pharmaceutical biofilms, especially those in water systems, thrive on fear and hype. No long term biofilm control can be achieved using a one-size-fits-all set of rules for design and operation. Biofilm can be controlled only when it is fully grasped. This is all the more important because each water system is unique. Water systems professionals need to get to the root of how biofilm grows into their system, which, obviously, would be quite different from any other system.

This is why those in water systems need to have proper insights into what actually lies behind some common water system designs. They need to clear the air about several misconceptions on the topic.

Solid understanding of water systems

It is to clear these myths and misconceptions that the world-acclaimed guru of water systems, Dr. Teri Soli, will be presiding over a seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. He has authored the complete rewrite of USP Chapter 1231, which many consider to be USP’s “pharmaceutical water bible”.

Want to understand the ways of implementing a water system that fulfils the conditions set out by the regulatory agencies? Just log on to All about Microbial Control, Monitoring, Validation and Troubleshoo... to enroll for this highly practical and useful seminar. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Learning on all aspects of water systems

In this microbiology-focused education about all aspects of water systems, Dr. Soli will offer knowledge of the proper design, validation, operation, monitoring, maintenance, troubleshooting, and excursion investigations of a high purity water system.

This interesting and interactive session will give participants insights into what actually lies behind some common water system designs and will bust a few myths about the same. The learning imparted at this course will is translatable to any system, with the result that uneventful microbial control can be achieved. This is the foundation to effective operation and design. Without this understanding, participants will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far outweigh the educational costs that could have prevented it.

Knowledge of water system validation and Change Control

A good way to get understanding of this topic is to be familiar with water system validation and Change Control. This knowledge is necessary to help them come up with ways of improving outcomes and reducing the frequency of excursion investigations. Dr. Soli will offer understanding on this at this seminar.

Dr. Soli has set out the following agenda for this seminar:

  • What makes water systems have microbial quality problems
  • Successful sanitization approaches for trouble-free water quality
  • Water system validation by logic instead of tradition
  • Understanding and controlling endotoxin
  • Harmonizing vs optimizing water microbial testing for system quality control
  • Microbial enumeration issues with high purity water systems
  • Water system investigation “how to’s” and example case studies
  • What USP Does and Doesn’t Say about PW, WFI, Pure Steam and Micro Issues.

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