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
Ozone
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
webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com
Phone: 800-447-9407
Fax: 302-288-6884