Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel by globalcompliancepane


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    Live Webinar          on
     Water System Biofilm Control and Microbial Monitoring Myths

     Course "Water System Biofilm Control and Microbial Monitoring
     Myths" has been pre-approved by RAPS as eligible for up to 1.5
     credits towards a participant's RAC recertification upon full
                                                                                                  Register Now                          


    Date & Time:                                                                             Instructor Profile:

     Wednesday, September 26,
                                          10:00 AM PDT | 01:00 PM EDT
     2012                                                                                                    Teri C. Soli
                                                                                                      Principal Consultant, Soli
     Duration: 90 Minutes                 Instructor: Teri C. Soli                                        Pharma Solutions

     Location: Online                     Price : $245.00   (for one participant)
                                                                                             T.C. Soli, is a Ph.D. Microbiologist
                                                                                             and President of Soli Pharma
                                                                                             Solutions, Inc.
    Overview:                                                                                (www.solipharmasol.com), and since
    It is an unfortunate fact that most water systems today have been                        becoming a full time consultant, has
    designed and are operated and controlled using at least some                             served consumer products and FDA-
    traditional concepts and methods that are downright wrong. So how                        regulated industries with training and
                                                                                             troubleshooting expertise covering
    could such traditions become so ingrained and be so wrong? How
                                                                                             water systems, sterilization, aseptic
    could well-intentioned benchmarking be so misguided?
                                                                                             processing, microbiological and beta-
                                                                                             lactam contamination control,
    There are many reasons, which will be discussed, but regardless of                       microbiological laboratory
    the causes, we need to be aware of these myths and understand                            operations, and has served as a
    how it really should be done. A number of water system myths will                        pharmaceutical expert witness in
    be discussed that are related to microbial control approaches as well                    several "contamination" litigations.
    as microbial monitoring. Each myth will be explained as to its origin                    Prior to full time consulting, he had
                                                                                             25 years of diverse "Big Pharma"
    and then put into true context with how the supposed microbial
                                                                                             operating company experience.
    control or monitoring approach SHOULD be handled. You will
                                                                                             During his 31+ year career he has
    probably be surprised to learn which of your "rules of thumb" are                        lectured extensively at conferences,
    actually quite wrong!                                                                    authored numerous papers and
                                                                                             recently written several book
                                                                                             chapters related to water system
    Areas Covered in the Session:
                                                                                             microbiology for USP, PDA and ISPE
                                                                                             publications. He is currently serving
       l   Why water myths develop                                                           in his third five-year term on USP
             ¡ Impact of c-GMPs                                                              Expert Committees responsible for
                                                                                             Pharmaceutical Waters through
             ¡ Well-meaning but misguided precedents
                                                                                             which he authored the complete
               ¡Scientifically unchallenged traditions and benchmarking
                                                                                             rewrite of USP Chapter <1231>
               ¡Rule-hungry culture                                                  
                                                                                             which many consider to be USP's
       l   Water System Microbial Control Myths                                              "pharmaceutical water bible".
               ¡   WFI from RO                                                               ...more
               ¡   Turbulent Flow and Flow Rate
               ¡   Dead Leg Rules
               ¡   Smooth Surfaces
                                                                                            Suggest a Topic       More Webinars
               ¡ In-Line Sterilizing Filters
              ¡ Ozone                                                                         Your Necessity is our Priority
       l   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

    Click here to register for this webinar

    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:

       l   Validation managers and personnel
       l   Engineers involved in water system design and installation
       l   Utility operators and their managers involved in maintaining
           and sanitizing water systems
       l   QA managers and Regulatory Affairs personnel involved in
         defending water system operations and quality data to FDA
         and EMEA inspectors and outside auditors
     l   QA managers and personnel involved in investigations of
         excursions and preparing CAPAs
     l   QC laboratory managers and personnel involved in sampling,
         testing, and trending chem and micro data from water systems
     l   Consultants and Troubleshooters

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,

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