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? 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
- High TOC
- The Sloppy Lab
- Flanged PolyPro System
- The Stealthy Dead Leg
- Parting kernels of water system wisdom
Teri C. Soli,
Principal Consultant ,
Soli Pharma Solutions
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.
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