[ÖRFÍ] Fw: Live Webinar on Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems

[Linda Helgadóttir]

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Kveðja, Linda

M.Linda Helgadóttir, lífeindafræðingur
Sýklafræðideild LSH, v/Barónsstíg
Netfang:lindah at landspitali.is
Sími: 543-5650

----- Forwarded by Linda Helgadóttir/RLSH/Landspitali/IS on 18.09.2014 
15:39 -----

From:   "Compliance Training" <training at info.globalcompliancepanel.com>
To:     lindah at landspitali.is
Date:   04.09.2014 13:07
Subject:        Live Webinar on Curtailing Microbial Excursions and 
Investigations in Pharmaceutical Water Systems



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GlobalCompliancePanel Your Gateway to Regulatory Compliance
Live Webinar on
Curtailing Microbial Excursions and Investigations in Pharmaceutical Water 
Systems 


Date: Tuesday, September 16, 2014 
Time: 10:00 AM PDT | 01:00 PM EDT 

Duration:
90 Minutes 

Register Now

Location:
Online
Instructor:
Teri C. Soli

Overview:
Water system microbial excursions are the bane of laboratories, utility 
operations, and production, often causing huge expenditures of labor for 
system sanitization and additional testing and quarantines of whole 
systems or specific outlets while fruitless investigations are mounted, 
not to mention the potential cost of product rejections when root causes 
are not definitive.

Areas covered in the session: 
What are excursions? 
Water system dilemma: process control or quality control (utility or raw 
material), or both 
Intended functions of Alert/Action Levels and Specifications 
Investigation, necessary and often fruitless 
Excursion responses and impact 
Criticality of valves, hoses, & outlet flushing 
Diagnosing the source of the problem 
Minimizing unnecessary excursion responses through best practices


Who Will Benefit: 
QA managers and personnel involved in investigations of excursions and 
preparing CAPAs
QC managers and personnel involved in sampling, testing, and trending chem 
and micro data from water systems
Utility operators and their managers involved in maintaining and 
sanitizing water systems
Validation managers and personnel
QA managers and other personnel involved in Change Control programs
QA managers and Regulatory Affairs personnel involved in defending water 
system operations and quality data to FDA and EMEA inspectors and outside 
auditors
Consultants and Troubleshooters

About Speaker 

Teri C. Soli
Principal Consultant, Soli Pharma Solutions 
Teri 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. Prior to full time consulting starting in 2004, he had 25 
years of pharmaceutical operating company experience. He has lectured 
extensively at conferences and webinars, authored numerous papers and 
written several book chapters related to water system microbiology and 
biofilm control for USP, PDA and ISPE publications. He is currently 
serving in his third five-year term on USP Expert Committees responsible 
for Pharmaceutical Waters during which he completely rewrote US P Chapter 
which many consider to be USP's "pharmaceutical water bible". ...more



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