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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
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
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
(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
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
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
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
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
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.
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