Overview: This webinar will assist the attendees in logically investigating and defining the specific quality attributes their lab 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 a full-fledged water system, but these water sources must also meet all compendial water quality requirements. They have 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. The various water standards will be reviewed, and the true compendial and other regulatory expectations will be presented, including those from USP and EP as well as from ASTM, ICH, ISO and CLSI. But establishing the correct specifications is only half the struggle. The other half is verifying the consistency of the system to maintain this quality - i.e. Validation.
Depending on the lab water source, validation may not always be necessary, but where it is, it may be 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 adjuncts to 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 appropriate laboratory water quality attributes and how that impacts the water sources used, as well as lab water system design, 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 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.
Areas Covered in the Session:
What quality do you really need?
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 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.
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
Event Link - http://bit.ly/1j6dMrH
161 Mission Falls Lane,
Suite 216, Fremont, CA 94539, USA
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