Compliance4All, Online Event
2016-09-12
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?
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: 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
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