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
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 ¡ ¡
l l l l l l l l
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 Control (Chem and Micro) Process and Design
Engineering Process Automation
Manufacturing Operations Validation Utility Operations
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Published on Oct 4, 2012
Contamination during removal of pristine water from a pharmaceutical water system is likely responsible for as much as 90% of all water syst...