Speaker Profile

Teri C. Soli
Principal Consultant, Soli Pharma Solutions

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and is a consultant serving consumer products and FDA-regulated industries with training and contamination troubleshooting expertise covering water systems, sterile and non-sterile products and processes, and microbiological laboratory operations. Prior to full time consulting starting in 2004, he had 25 years of pharmaceutical operating company experience. He has lectured extensively at conferences and webinars, authored numerous papers and written several book chapters related to water system microbiology and biofilm control for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters during which he completely rewrote USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible".

Speakers

Common Sense Water System Validation

Water system validation is often considered a necessary evil intended to merely satisfy a regulatory expectation. If done using a one-size-fits-all template, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable "insurance policy". All water systems are different and have different challenges in consistently purifying and delivering acceptable water to users.

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Guarding Against Common Pharmaceutical Water System Inspection Pitfalls

This webinar explains the issues and techniques that regulators may use when investigating your water systems for "GMP flaws". More than likely, even the most quality-conscious organization has some water system "skeletons" in their closets, perhaps unwittingly. These "skeletons" or deficiencies are often connected with the site’s Quality Systems and are indicative of your Quality Systems health, so having an uneventful water system audit (which would be facilitated by attending this webinar and proactively addressing the issues presented therein) could keep the regulators out of other typically fertile territory for regulatory deficiencies found elsewhere at your site.

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Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.

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Key Concepts in Successful Water System Sanitization

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.

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Laboratory Water Systems: Necessary Water Specifications and Validation Challenges

Laboratory water systems are often the forgotten, red-haired stepchild of pharmaceutical operations. Yet, in some ways, the maintenance of the appropriate quality of lab water systems is perhaps more important than many applications of manufacturing's water systems since the tests performed on manufacturing's products can be affected by the lab water quality in insidious, hard to detect ways, which could cause perfectly good products to appear to fail testing or bad product to appear to pass. Often too little effort is invested in understanding and maintaining lab water systems for a number of reasons that will be discussed. On the other hand, excessive effort may be expended in maintaining certain water attributes that are neither required nor consequential for the vast majority of analyses, such as the microbiological content.

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