“Water System Bio-film Control and Microbial Monitoring Myths” from GlobalCompliancePanel

An unfortunate, yet undeniable fact of water systems is that many of them are designed keeping obsolete concepts in mind. The result of an organization’s reluctance to update its water systems is that the systems are built on a shaky foundation.

Online PR News – 01-February-2013 – Fremont – Description:
An unfortunate, yet undeniable fact of water systems is that many of them are designed keeping obsolete concepts in mind. The result of an organization’s reluctance to update its water systems is that the systems are built on a shaky foundation, making them weak at their core.
This webinar will discussion some detail the reasons for which such fallacies happen, but greater attention will be paid to how these systems can be corrected. For this to happen, a few established myths have to be shattered. This session seeks to quell popular myths surrounding water systems, for most important reason for which water systems go awry. Most of these myths relate to microbial control approaches and microbial monitoring.
The speaker brings his over three decades of experience in water systems in taking up each myth for demystification. This session will cover the following areas:
o Why water myths develop:
Impact of c-GMPs
Well-meaning but misguided precedents
Scientifically unchallenged traditions and benchmarking
Rule-hungry culture
o Water System Microbial Control Myths:
WFI from RO
Turbulent Flow and Flow Rate
Dead Leg Rules
Smooth Surfaces
In-Line Sterilizing Filters
Ozone
o 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
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When:February 5, 10:00 AM PDT | 01:00 PM EDT
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By whom:
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. The areas he has covered include water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control and microbiological laboratory operations. Soli has also 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 has 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 1231, which many consider to be USP's "pharmaceutical water bible".
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For whom:
The webinar will benefit
1. Validation managers and personnel
2. Engineers involved in water system design and installation
3. Utility operators and their managers involved in maintaining and sanitizing water systems
4. QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
5. QA managers and personnel involved in investigations of excursions and preparing CAPAs
6. QC laboratory managers and personnel involved in sampling, testing, and trending chemical and micro data from water systems
7. Consultants and troubleshooters
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Duration: 90 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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Contact Information
John Robinson
GlobalCompliancePanel
Fremont California, 94539
18004259407