ComplianceOnline

Water System Investigation Elements and Contamination Case Studies

Instructor: T.C Soli
Product ID: 701585
Training Level: Intermediate
  • Duration: 90 Min

recorded version

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Read Frequently Asked Questions

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.

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:

Dr. Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE’s Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

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