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Pharmaceutical Water System Use & Monitoring: Avoiding Problems by Doing It Right, & The Practicality of Real-Time Release
Course "Pharmaceutical Water System Use & Monitoring: Avoiding Problems by Doing It Right, & The Practicality of RealTime Release" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification
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upon full completion. Instructor Profile:
Date & Time: Tuesday, April 17, 2012
10:00 AM PDT | 01:00 PM EDT
Duration: 90 Minutes
Instructor: Teri C. Soli
Location: Online
Price : $245.00
Teri C. Soli Principal Consultant, Soli Pharma Solutions
(for one participant)
Overview: Problematic removal of pristine water from a pharmaceutical or other high purity water system, for use in manufacturing, cleaning or for sampling, is likely responsible for as much as 90% of all water system deviations. Done properly, it can lead to greatly reduced product or process contamination, improved water system control and avoidance of time-consuming and frustratingly inconclusive problem investigations. At the heart of the problem is a fundamental misunderstanding of the purposes and practice of sampling and testing, and how to most effectively use the resulting data to improve manufacturing's water use practices and maintain water system control before problems arise from biofilm-related contamination. This presentation will correct these misunderstandings and explain practical best practices for outlet use and sampling to reflect the true water quality, including grab samples and on-line testing, that could pave the way to adoption of dramatic resource saving Real-Time Release approaches for BOTH chemistry and microbiological attributes of these waters.
Areas Covered in the Session: l
Importance of proper sampling
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Process or Raw Material? Uses of water sampling data – PC or QC? Data use impact on sampling locations for Data use impact on microbial sampling techniques
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Sampling plan options Test method options Practicality of real time release
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 FDAregulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and betalactam 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". ...more
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Click here to register for this webinar Who Will Benefit: This presentation is targeted toward the following organizational positions and disciplines and is presented in practical language understandable by all technically educated or trained individuals, regardless of specialty. This information would be useful at levels from senior management to operative, and would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to water: l l l l l l l l
Quality Assurance Quality Control (Chem and Micro) Process and Design Engineering Process Automation Manufacturing Operations Validation Utility Operations Regulatory Affairs
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