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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?
Areas Covered in the Session:
Why water myths develop
Impact of c-GMPs
Well-meaning but misguided precedents
Scientifically unchallenged traditions and benchmarking
Water System Microbial Control Myths
WFI from RO
Turbulent Flow and Flow Rate
Dead Leg Rules
In-Line Sterilizing Filters
Microbial Enumeration Myths
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:
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
Teri 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.
Compliance4All DBA NetZealous,
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