This Water system compliance training/webinar focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches.
Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success.
This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization.
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Are you water system sanitizations having to be repeated more and more frequently.
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Are you wasting a small fortune in water system sanitizing chemicals and labor, as well as lost manufacturing time, and the sanitizations don't seem to have a lasting effect on water quality.
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Are you sanitizing when you see high counts only to see them reappear days later.
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Are your microbial data trends showing increasingly higher counts in spite of remedial efforts.
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Are you now starting to see P. aeruginosa or B. cepacia in your water system counts.
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All these are symptoms that your sanitization efforts are ineffective and need to be remedied!
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Areas Covered in the seminar:
- Understand the basic water system sanitization concepts.
- Use this understanding to design effective microbial control measures for your water systems.
- Use this understanding to solve microbial problems originating from poor sanitization practices.
- Debunk a few water system myths related to sanitization.
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:
- Engineers involved in water system design.
- Utility operators and their managers involved in maintaining and sanitizing water systems.
- QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels.
- QA managers and personnel involved in investigations of excursions and preparing CAPAs.
- QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems.
- Validation managers and personnel.
- 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, 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, microbiological laboratory operations, and 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.
During his 30 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. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.
