This Water system compliance training cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.
Most people who design, maintain, and monitor WFI systems have heard of biofilm and know a little about endotoxin, but may not realize where it can come from in the water system, how to control those sources, or how to "clean up" endotoxin once it has contaminated water, APIs, or equipment. In spite of a superficial knowledge about the bacterial origin of endotoxin, they may not realize the diversity of its composition and potency from various bacterial sources, how it behaves in water, as well as the medical complications it causes, which is the reason behind the various endotoxin specifications for the compendial bulk and packaged waters or the molecular amplification mechanisms behind the relatively simple-to-run but exquisitely sensitive and easily compromised LAL test.
This presentation will cover all these issues and more so that the attendee can have a better appreciation of the endotoxin test, a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water and possibly into finished products, and where to implement effective corrective actions.
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An endotoxin excursion in a WFI system is a relatively rare but disastrous event. Are you prepared to respond rapidly and effectively to correct the problem before the scope of product impact further broadens.
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Learn what can be done or monitored to avoid such a disaster by using carefully crafted Alert and Action Levels to warn of impending disaster and allow corrections to be made before being overtaken.
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A lack of knowledge of how the LAL endotoxin test works can lead to misinterpretation of test results or invalid results.
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Some regulators perceive that stills can reduce incoming endotoxin levels by a relatively small amount. Find out how well you still actually perform before you receive a 483 for not knowing or not controlling the incoming endotoxin to manageable levels.
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Areas Covered in the seminar:
- Where does endotoxin come from?
- What are the properties of endotoxin?
- How do you get rid of it?
- How do you detect it?
- What assay controls are used?
- What are the endotoxin specs for water?
- How do you control it?
Who will benefit:
This webinar will be valuable for all companies that operate WFI 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 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>.
