Usa 2016 Conference on Water System Biofilm Control and Microbial Monitoring Myths

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

Speaker Profile:

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.

Contact Detail:

Compliance4All DBA NetZealous,

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Email: support@compliance4All.com

http://www.compliance4all.com/

Event Link : http://bit.ly/2a458lA

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