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Overview: This webinar will assist the attendees in logically investigating and defining the specific quality attributes theirlab water systems need and not just default to manufacturing's required water quality. The need or lack thereof to validate your water system will also be discussed along with how that validation may be very different from that employed for manufacturing's water system. So you may not be doing enough for your water system or you might be going well overboard. Using packaged waters and/or small self-contained water purification systems are often considered alternatives to having and maintaining afull-fledged water system, but these water sources must also meet all compendial water quality requirements. Theyhave unique and often unrealized challenges that may make them less cost effective than thought. The quality of water used by a pharmaceutical testing laboratory is crucial to the reliability and accuracy of the data that laboratory generates. The needed quality of that water is often misunderstood because it is a function of the types of tests being performed as well as regulatory requirements which are often different from common perceptions. Firms often make the mistake of requiring exactly the same water quality in the lab as used by manufacturing, but the necessary water quality could be very different. This webinar will provide the guidance needed to make a science-based decision on what water quality is needed for the analyses as well as to remain compliant with regulatory expectations. a very different protocol that has been used for manufacturing's water systems, so these important issues will also be discussed. Small bench-top or wall-mounted purification units or even packaged waters are sometimes considered as adjunctsto or cost-avoiding replacements to full-fledged lab water systems, but each comes with various advantages and disadvantages that may not be obvious which could neutralize any cost savings, so these will also be discussed. All in all, the attendees will undoubtedly better understand the importance of establishing appropriatelaboratory water quality attributes and how that impacts the water sources used, as well as lab water systemdesign, maintenance, monitoring, and validation in ways they probably didn't realize were important to not only maintaining regulatory compliance but also to assuring the continuous suitability of their lab's water for their particular analytical uses. Why Should You Attend: 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 causeperfectly 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 attributesthat are neither required nor consequential for the vast majority of analyses, such as the microbiological content. Areas Covered in the Session: What quality do you really need? Required attributes Perhaps unnecessary attributes Lab water supply options Lab water system design issues Lab water system validation Needed or not? Customized to attributes of importance Packaged water options and issues Who Will Benefit: This webinar will be valuable for all companies with in-house laboratories as well as, especially, for contract laboratories for FDA and EMA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit attending include: Validation managers and personnel Engineers involved in water system design and installation Personnel and their managers involved in maintaining laboratory water systems QA managers and Regulatory Affairs personnel involved in defending lab water system operations and quality data to FDA and EMA inspectors and outside auditors QC laboratory managers and personnel involved in sampling, testing, and trending data from lab water systems QC analysts and their supervisors who use the lab water Consultants and Troubleshooters 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 31+ year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for USP, PDA and ISPE publications. He is currently serving in his third five-year term on USP Expert Committees responsible for Pharmaceutical Waters through which he authored the complete rewrite of USP Chapter <1231> which many consider to be USP's "pharmaceutical water bible". AMAZINES.COM
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Online Training, Validation Challenges, Laboratory Water Systems, Water Specifications, manufacturing's water systems,
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