The A to Z's of Microbial Control, Monitoring and validation of Pharmaceutical Water Systems - 2-day In-person Seminar

Event Details

Time: April 9, 2015 at 9am to April 10, 2015 at 6pm
Location: Los Angeles, California, United States
Street: 120 South Los Angeles Street, Los Angeles, California, 90012, USA
City/Town: Los Angeles
Website or Map: https://www.globalcompliancep…
Phone: 18004479407
Event Type: food, health, care, medical, device, mining, aerospace, and, navy, fda
Organized By: GlobalCompliancepanel
Latest Activity: Feb 12, 2015

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Event Description

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential to the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don't work and can cause very costly system downtime or even product recalls.

Why should you attend:

Are you having persistent water system problems - nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that biofilm has taken over and you can't get rid of it?

These are common concerns that primarily originate out of ignorance of appropriate design, maintenance, sanitization, sampling, and testing for your water system. Attending this 2-day course will open your eyes to what is really going on in your water system and how to "get it right", finally! Can you afford to remain ignorant and repeat the problems of the past or should you attend this course to replace that ignorance with the knowledge that will allow you to get the water system under control.

Who will benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel who desire to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific employee positions that would benefit are:

Microbiology Laboratory supervisors and analysts responsible for water sampling and testing
Quality Assurance personnel responsible for water system deviation management and change control
Regulatory and Compliance professionals responsible for FDA interactions
Process and Utility Engineers responsible for water system maintenance, troubleshooting, and excursion mitigation
Facility Engineers responsible for water system design or renovation
Validation personnel for water system qualification

Speaker:

Dr. Teri C. ("T.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.

Price: $1,295.00

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