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

Why Should You Attend:

Have you ever encountered what appeared to be a water system problem or worse, a product contaminated with a water-type organism? If so, you already know there is no rule book on how to find the root cause and resolve the problem. However, you can take some pointers from a consultant who makes a living doing this very thing and see some intriguing case studies where his approach was used to resolve the problems. If you are involved in these kinds of investigations and problem-solving, you can't afford to miss this webinar.

This webinar explains the elements of such investigations that can be used, some of the pitfalls and red herrings that will be encountered, and some actual (but anonymous) case studies where the author has resolved problems that may not be too different from some with which you may have struggled.

Areas Covered in the Seminar:

• Gathering and using existing information/opinions
• Investigation approach: what stones to turn over
• Discovering a root cause and mitigation strategy
• Obstacles to remediation
• 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

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:

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

T.C Soli
President, Soli Pharma Solutions, Inc.

Dr. Teri C. ("T.C.") Soli ,Ph.D. is President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and has been consulting full time for 5 years, serving consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. Prior to consulting, he had 25 years of diverse "Big Pharma" operating company experience.

Topic Background:

There is no rule book or SOP for problem-solving when it comes to water system contamination or products that appear to have been contaminated by water organisms. One can always over-react by changing many suspect practices, but quite often, the problems return because the root cause was not squarely addrressed. Frankly, the skill to find the true root causes and solve these sometimes very complex problems is usually learned from experience using a firm understanding of biofilm, awareness of good (and bad) manufacturing and laboratory practices, an little understanding of human psychology, and healthy doses of curiosity and common sense.

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