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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. Prior to full time consulting starting in 2004, he had 25 years of pharmaceutical operating company experience. Quick Contact: GlobalCompliancePanel USA Phone:800-447-9407 Fax: 302-288-6884 support@globalcompliancepanel.com http://www.globalcompliancepanel.com
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