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Phone: 800-447-9407

RAPS Approved Webinar on

Pharmaceutical Water System Sampling: Avoiding Problems by Doing It Right & The Practicality of Real-Time Release Date: Thursday, November 8, 2012

Time: 10:00 AM PDT | 01:00 PM EDT

Course "Pharmaceutical Water System Sampling: Avoiding Problems by Doing It Right & The Practicality of Real-Time Release" has been preapproved by RAPS as eligible for up to 1.5 credits towards a participant's RAC recertification upon full completion.

Duration: 90 Minutes Instructor: Teri C. Soli Location: Online Price : $245.00 (for one participant)

Teri C. Soli Principal Consultant, Soli Pharma Solutions

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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, ...more

Overview: Contamination during removal of pristine water from a pharmaceutical water system is likely responsible for as much as 90% of all water system deviations. Done properly, sampling 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 RealTime Release approaches for BOTH chemistry and microbiological attributes of these waters.

Areas Covered in the Session: l l l l

Importance of proper sampling Process or Raw Material? Uses of water sampling data – PC or QC? Data use impact on sampling locations for ¡ Chemical testing Endotoxin testing Microbial testing Data use impact on microbial sampling techniques Sampling plan options ¡ ¡

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Test method options Practicality of real time release Data use impact on microbial sampling techniques Sampling plan options Test method options Practicality of real time release

Who Will Benefit: l

Quality Assurance

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Quality Control (Chem and Micro) Process and Design

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Engineering Process Automation

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Manufacturing Operations Validation Utility Operations

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Regulatory Affairs

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Event-coordinator GlobalCompliancePanel About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions, giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs. GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning and development on/through our website. Keep track of all webinars arranged for your industry through notifications & event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for professionals. GlobalCompliancePanel www.globalcompliancepanel.com

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Pharmaceutical Water System Sampling - Webinar By GlobalCompliancePanel  

Contamination during removal of pristine water from a pharmaceutical water system is likely responsible for as much as 90% of all water syst...

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