2-day In-person Seminar on The A to Z's of Microbial Control, Monitoring, Validation and Troubleshooting of Pharmaceutical Water Systems New Jersey by globalcompliancepane


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    2-day In-person Seminar on
      The A to Z's of Microbial Control, Monitoring, Validation and
      Troubleshooting of Pharmaceutical Water Systems

     Course "The A to Z's of Microbial Control, Monitoring, Validation
     and Troubleshooting of Pharmaceutical Water Systems" has
                                                                                             Register Now                         
     been pre-approved by RAPS as eligible for up to 12 credits
     towards a participant's RAC recertification upon full completion.

    Date & Time:                                                                       Instructor Profile:

     October 11th and 12th 2012            8 AM to 5 PM EDT
                                                                                                       Teri C. Soli
     Duration: 2 Days                      Instructor: Teri C. Soli                             Principal Consultant, Soli
                                                                                                    Pharma Solutions
                                           Price : $1295.00   (for one
     Location: New Jersey
                                                                                       T.C. Soli, is a Ph.D. Microbiologist
              Register for 4 Participants to Get 1 Free Pass                           and President of Soli Pharma
                                                                                       Solutions, Inc.
                                                                                       (www.solipharmasol.com), and since
                                                                                       becoming a full time consultant, has
                                                                                       served consumer products and FDA-
    This course is designed to provide a microbiology-focused education                regulated industries with training and
    about all aspects of water systems and how biofilm manages to                      troubleshooting expertise covering
    thrive there.                                                                      water systems, sterilization, aseptic
                                                                                       processing, microbiological and beta-
                                                                                       lactam contamination control,
    Prior microbiological education or training, though a plus, is not a
                                                                                       microbiological laboratory
    requirement because engineers and other non-biologists also need
                                                                                       operations, and has served as a
    this training if they are involved with any aspect of water systems.               pharmaceutical expert witness in
    The instructor will provide the necessary background needed to                     several "contamination" litigations.
    understand this very important subject matter.  This understanding                 Prior to full time consulting, he had
    is essential to the proper design, validation, operation, monitoring,              25 years of diverse "Big Pharma"
    maintenance, troubleshooting, and excursion investigations of a high               operating company experience.
    purity water system. Without this understanding, water system                      During his 31+ year career he has
                                                                                       lectured extensively at conferences,
    control consists of a set of rules that often don’t work and can cause
                                                                                       authored numerous papers and
    very costly system downtime or even product recalls, and leaves the
                                                                                       recently written several book
    user without a clue as to what went wrong or how to effectively fix it             chapters related to water system
    so it doesn't recur.                                                               microbiology for USP, PDA and ISPE
                                                                                       publications. He is currently serving
                                                                                       in his third five-year term on USP
     Course Outline:
                                                                                       Expert Committees responsible for
                                                                                       Pharmaceutical Waters through
    Course Outline: Day 1:                                                             which he authored the complete
                                                                                       rewrite of USP Chapter <1231>
    Lecture 1: What Makes Water Systems Have Microbial Quality                         which many consider to be USP's
                                                                                       "pharmaceutical water bible".

        l   Understand biofilm basics and how it develops
        l   Understand the impact of biofilm on the commonly used
            purification unit operations                                              Suggest a Topic       More Webinars
        l   Understand how various commonly used microbial control
                                                                                        Your Necessity is our Priority
            strategies work (or don’t work) to control biofilm development
        l   Understand the how, where, and why of microbial monitoring,
            action levels, etc.
        l   Debunk a few water system myths
        l   Get answers to your own water system questions

    Lecture 2: Successful Sanitization Approaches for Trouble-Free
    Water Quality

        l   Material and construction limitations
        l   Continuous vs intermittent sanitization
        l   The importance of biofilm removal
        l   How sanitants work (or don’t work)
        l   When to sanitize
        l   Troubleshooting sanitization problems

    Lecture 3: Water System Validation by Logic Instead of Tradition

        l   Why validate a water system?
        l   Basic ground rules for water systems before you validate them
   l   Micro Test Method “validation”
   l   Minimum validation expectations
   l   How to figure out what you should validate
   l   What happens after the honeymoon is over
   l   Is validation ever really over?
   l   Special considerations for lab water systems
   l   Are packaged waters a viable option?

Lecture 4: Implementing Changes to a Validated System

   l   Purpose of a Change Control program – a help, not a
   l   When is a change major vs minor, requiring full vs limited re-
   l   What about water use during re-qualifications?
   l   FDA validation expectations
   l   Reliance on logic and common sense and the disservice of
       precedent and paradigms
   l   Additional useful tips

Lecture 5: Reducing Water Microbial Excursions & Improving

   l   What are excursions?
   l   Water system dilemma: process control or quality control
       (utility or raw material), or both
   l   Intended roles of Alert/Action Levels and Specifications          
   l   Investigation, necessary and often fruitless
   l   Excursion responses and impact
   l   Criticality of valves, hoses, & outlet flushing
   l   Diagnosing the source of the problem
   l   Minimizing unnecessary excursion responses through best

Course Outline: Day 2:

Lecture 6: Understanding and Controlling Endotoxin

   l   Where does endotoxin come from?
   l   What are the properties of endotoxin ?
   l   How do you get rid of it?
   l   How do you detect it?
   l   What assay controls are used?
   l   What are the endotoxin specs for water?
   l   How do you control it?

Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for
System Quality Control

   l   Water harmonization that has occurred
   l   Water Micro TM “Dis-Harmonization”
   l   A little about Biofilm
   l   Biofilm diversity in water systems
   l   Micro TM options and evaluation protocol
   l   The good and bad of Micro harmonization
   l   Where RMMs can fit in
   l   Parting wisdom

Lecture 8: Microbial Enumeration Issues with High Purity Water

   l   Biofilm enumeration issues (planktonic vs surface)
   l   Traditional cultivative approach issues
   l   Validation of your test method
   l   Alternative TM choices (advantages/disadvantages)
   l   Significance of water isolates
   l   Sampling issues
   l   Establishing Alert/Action Levels and Water Specs and
       defending them to FDA

Lecture 9: Water System Investigation "How-To's" and Example
Case Studies

   l   Gathering and assessing existing data and symptoms
   l   Considering user opinions
   l   Investigation approach elements
   l   Recognizing red herrings/false positives
   l   Recognizing possible root causes
   l   Water system contamination case studies
   l   Parting kernels of water system wisdom
 Lecture 10: What USP Does and Doesn’t Say about PW, WFI,
 Pure Steam and Micro Issues

     l   PW, WFI, Pure Steam micro specifications?
     l   <1231> Starting water issues
     l   <1231> Misunderstood issues clarified
     l   <1231> Microbiological test issues clarified
     l   <1231> Suggested micro test method
     l   <1231> Micro Specifications
     l   <1231> Alert and Action Levels and max’s
     l   Recent/Upcoming USP water changes
     l   Discrepancies between pharmacopeia’s
     l   New water initiatives – need your input/feedback

 Click here to register for this seminar

  Who Will Benefit:

     l   Microbiology Laboratory supervisors and analysts responsible
         for water sampling and testing
     l   Quality Assurance personnel responsible for water system
         deviation management and change control
     l   Regulatory and Compliance professionals responsible for FDA
     l   Process and Utility Engineers responsible for water system
         maintenance, repairs, troubleshooting, and excursion
     l   Facility Engineers responsible for water system design or
     l   Validation personnel for water system qualification
     l   Change Control personnel involved in water system changes
         and repairs
     l   Production Managers involved with water system use for
         manufacturing and cleaning
     l   Laboratory Managers and Supervisors responsible for lab
         water systems and other water sources

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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