"Pharmaceutical Water System Use & Monitoring: Avoiding Problems by Doing It Right &the Practicality of Real-Time Release"

(prHWY.com) September 21, 2012 - Wilmington, DE -- Description:No less than 90% of all water system deviationsoccur due to contamination during removal of pristine water from a pharmaceutical water system. The answer to this problem is to carry out samplingproperly, which is a great tool for reducing product or process contamination. This can bring about improved water system control and prevent problem investigative processes that turn out to be expensive, long winding and eventually, fruitless.
This webinar will cover all the important aspects of how to use optimal sampling to put an improved water system control in place, which will eliminate deviations and lead to enhanced and more effective investigative processes. Participants of this webinar will learn to use the sampling data to improve manufacturing's water use practices and maintain water system control before problems related to from biofilm-related contaminationcrop up.
This session will offer practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, the aim of which is to foster adoption of resource saving Real-Time Release approaches for both chemistry and microbiological attributes of these waters.
Areas Covered in the Session:
o Importance of proper sampling
o Process or Raw Material?
o Uses of water sampling data - PC or QC?
o Data use impact on sampling locations for
ï€ Chemical testing
ï€ Endotoxin testing
ï€ Microbial testing
o Data use impact on microbial sampling techniques
o Sampling plan options
o Test method options
o Practicality of real time release
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When:November 8, 10:00 AM PDT | 01:00 PM EDT
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By whom:
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. The areas he has covered include water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control and microbiological laboratory operations. Soli has also 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 has 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".
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For whom:
The webinar will benefit
o Quality Assurance
o Quality Control (Chemistry and Micro)
o Process and Design Engineering
o Process Automation
o Manufacturing Operations
o Validation
o Utility Operations
o Regulatory Affairs

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Duration: 90 minutes
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To enroll for this webinar, contact
webinars@globalcompliancepanel.com
Phone: 800-447-9407

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