2015 - In-person Workshop on Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems

Overview:
This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don't work and can cause very costly system downtime or even product recalls.
Why should you attend:
(Fear, uncertainty and doubt (FUD) liner for the marketing purpose)- Are you having persistent water system problems - nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that biofilm has taken over and you can't get rid of it?
These are common concerns that primarily originate out of ignorance of appropriate design, maintenance, sanitization, sampling, and testing for your water system. Attending this 2-day course will open your eyes to what is really going on in your water system and how to "get it right", finally! Can you afford to remain ignorant and repeat the problems of the past or should you attend this course to replace that ignorance with the knowledge that will allow you to get the water system under control.
Who will benefit:
This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel who desire to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific employee positions that would benefit are:
Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
Quality Assurance personnel responsible for water system deviation management and change control
Regulatory and Compliance professionals responsible for FDA interactions
Process and Utility Engineers responsible for water system maintenance, troubleshooting, and excursion mitigation
Facility Engineers responsible for water system design or renovation
Validation personnel for water system qualification
Agenda:
Day One
Lecture 1: Controlling Water System Biofilm Through Design & Operation
Microbial control - where and why it matters
Biofilm basics and how it develops
Biofilm impact on "active" surfaces
Environmental resistances of biofilm
Biofilm impact on purification unit operations and how to control it
Good design practices to control biofilm
Good maintenance practices to control biofilm
Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality
Material and construction limitations
Continuous vs intermittent sanitization
The importance of biofilm removal
How sanitants work (or don't work)
When to sanitize
Common causes for sanitization failures and troubleshooting sanitization problems
Lecture 3: Water System Validation by Logic Instead of Tradition
Why validate a water system?
Basic ground rules for water systems before you validate them
Minimum validation expectations
What happens after the honeymoon is over
Making changes to a validated water system
Special considerations for lab water systems
Are packaged waters a viable option?
Lecture 4: Understanding and Controlling Endotoxin
Where does endotoxin come from?
What are the properties of endotoxin ?
How do you get rid of it?
How do you detect it?
What assay controls are used?
What are the endotoxin specs for water?
How do you control it?
Lecture 5: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control
Water harmonization that has occurred
Water Micro TM "Dis-Harmonization"
Biofilm diversity in water systems
The good and bad of Micro harmonization
Where RMMs can fit in
Day Two:
Lecture 1: Microbial Enumeration Issues with High Purity Water Systems
Biofilm enumeration issues (planktonic vs surface)
Purpose of sampling and testing (PC vs QC)
Traditional cultivative approach issues
Validation of your test method
Alternative RMM choices (advantages/disadvantages)
Significance of water isolates
Lecture 2: Reducing Water Microbial Excursions & Improving Investigations.
What are excursions?
Water system dilemma: process control or quality control (utility or raw material), or both
Intended roles of Alert/Action Levels and Specifications
Investigation, necessary and often fruitless
Excursion responses and impact
Criticality of valves, hoses, & outlet flushing
Diagnosing the source of the problem
Minimizing unnecessary excursion responses through best practices
Lecture 3: Water System Investigation "How-To's" and Example Case Studies
Early information; user opinions
Investigation approach elements
Water system contamination case studies
The Beige Puddle
"TNTC"
High TOC
The Sloppy Lab
Flanged PolyPro System
The Stealthy Dead Leg
Parting kernels of water system wisdom
Lecture 4: The Hero of Manufacturing Contamination Control: The Microbiology Lab
How contamination is controlled
Why the microbiology lab should lead in contamination control
Routine contamination evaluation activities
Microbiological Training
Root cause and impact investigations
Impediments to leadership
Doing the right thing
Lecture 5: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues
PW, WFI, Pure Steam micro specifications?
<1231> Starting water issues
<1231> Misunderstood issues clarified
<1231> Microbiological test issues clarified
<1231> Suggested micro test method
<1231> Micro Specifications
<1231> Alert and Action Levels and max's
Recent/Upcoming USP water changes
Discrepancies between pharmacopeia's
New water initiatives - need your input/feedback
Speaker:
Dr. Teri C. ("T.C.") Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc.
(www.solipharmasol.com), and is a consultant serving consumer products and FDA-regulated industries with training and contamination troubleshooting expertise covering water systems, sterile
and non-sterile products and processes, and microbiological laboratory operations.
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