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.
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
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.
T.C. Soli, Ph.D, is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP.
Proven Root Cause Investigation Techniques for Pharmaceutical Water Systems
Product Type : On Demand Webinar
Author : T.C Soli
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