Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel

Wilmington, Delaware (PressExposure) April 19, 2012 -- Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided?

There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong!

Areas Covered in the Session:

Why water myths develop

Impact of c-GMPs

Well-meaning but misguided precedents

Scientifically unchallenged traditions and benchmarking

Rule-hungry culture

Water System Microbial Control Myths

WFI from RO

Turbulent Flow and Flow Rate

Dead Leg Rules

Smooth Surfaces

In-Line Sterilizing Filters


Microbial Enumeration Myths

Referee Methods

Thermophiles in Hot Systems

R2A, 35°C, 5 days

Test Filter Membrane Rating

Compendial Action Levels

TOC and Endotoxin as Microbial Count Correlates

Who Will Benefit: This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:

Validation managers and personnel

Engineers involved in water system design and installation

Utility operators and their managers involved in maintaining and sanitizing water systems

QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors

QA managers and personnel involved in investigations of excursions and preparing CAPAs

QC laboratory managers and personnel involved in sampling, testing, and trending chem and micro data from water systems

Consultants and Troubleshooters

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 covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience. During his 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter which many consider to be USP's "pharmaceutical water bible".

Tuesday, May 22, 2012

10:00 AM PDT | 01:00 PM EDT

Price List:

Live : $245.00

Corporate live : $995.00

Recorded : $295.00



Phone: 800-447-9407

Fax: 302-288-6884

About GlobalCompliancePanel

GlobalCompliancePanel is an online training gateway delivering high quality regulatory & compliance trainings in a simple, cost effective and in a user friendly format.

GlobalCompliancePanel offers a broad range of channels for broadcasting and exchange of information through web based training, web alerts & discussion forums.

Press Release Source: http://PressExposure.com/PR/GlobalCompliancePanel.html

Press Release Submitted On: April 19, 2012 at 7:38 am
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