In this Water System Webinar the author will explain the process he uses as a consultant for investigating and solving water system or product contamination problems with water organisms. Case studies of real life problems he has resolved will be presented to illustrate the process. Though there is no rule book or SOP for such contamination problem solving, learn the best practices of solving these problems from an expert.
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?
There is no rule book, SOP, or industry guidance for problem-solving when it comes to water system contamination or for products that appear to have been contaminated by organisms from a water system. One can always over-react by shutting down, resanitize the water system, and change many suspect practices, but quite often, the problems return because the “scatter-gun” approach did not squarely hit the root cause. 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, a little understanding of human psychology, and healthy doses of both curiosity and common sense.
This webinar explains the elements of such investigations that can be used as well as some of the pitfalls and red herrings that will be encountered, then illustrates these techniques with 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. You can take home some useful 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 activities, you can't afford to miss this webinar.
Areas Covered in the Seminar:
- Early information; gathering and assessing user opinions.
- Investigation approach elements-- the various rocks to be turned over.
- Five water system/product contamination case studies.
- Seven kernels of water system investigation 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
Instructor Profile:
T.C. Soli,
is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant 6 years ago, has served 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. He has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience with Pfizer, Burroughs Wellcome/Glaxo Wellcome, DSM and others.
During his 31 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. From 2005 – 2010 he was Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP's Chapter <1231> which many consider to be USP's “pharmaceutical water bible”. He has recently been elected to his third 5-year term on the USP Expert Committee responsible for Pharmaceutical Water.
