This Water system validation training will guide you how validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the microbial testing during validation and which ones need not be. Understanding the purpose of water system validation will allow you to see the fallacies of many standard protocol templates bred by tradition and do only what is appropriate for YOUR water system.

1. Logical Water System Validation
December 09, Thursday 10:00 AM PST | 01:00 PM EST
Why Should You Attend:
• Are you sure your water system was properly validated?
• Have you ever had chemical or microbial control problems with the water system that did not show up during
validation?
• Have those problems ever caused manufacturing interruptions?
• Have those problems ever caused product problems? Are you absolutely sure?
Though FDA is often glad to see that any sort of water system validation has been done, they will quickly raise their
expectations (and "483 pad") if your validation was poorly done and resulted in product/health problems. You can avoid this
regulatory attention as well as these product problems by applying a little logic to your validation protocol and avoiding
standard templates which may not be the right challenge for YOUR water system. However, to apply logic, you MUST
understand how your water system is intended to work and what could make it fail to do so. With every water system being
different, a customized validation protocol is a necessity. Attending this presentation will allow you to understand what water
system features are essential to include in validation (and which are not), and will also explore the validation needs of
laboratory water systems as well as issues related to supposedly cost-avoiding options like using package waters.
Validation is often considered a necessary evil and a waste of time to merely satisfy a regulatory expectation, and
because of the low expected return on investment, is typically performed using a standard template to minimize costs.
But what you get is essentially worthless. If the validation is done logically and properly, it can be a valuable "insurance
policy", especially for a water system.
Date: December 09, Thursday 2010
Time: 10:00 AM PST | 01:00 PM EST
Duration: 60 Min
Instructor: T.C Soli
Location: Your office or conference room (no need to travel!)
Areas Covered in the seminar:
• Why validate a water system?
• Basic ground rules for water systems before you validate them.
• Micro Test Method “validation”.
• Minimum validation expectations.
• How to figure out what you should validate.
• What happens after the honeymoon is over.
• Is validation ever really over?
• Special considerations for lab water systems.
• Are packaged waters a viable option?
T.C Soli
Register Now

2. Who Will Benefit:
This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in
FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields,
as well as consumer products and cosmetics companies. The employees who will benefit include:
• Validation managers and personnel
• QA managers and other personnel involved in Change Control programs
• Utility operators and their managers involved in maintaining and sanitizing water systems
• QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to
FDA and EMEA inspectors and outside auditors
• 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
• Consultants
Instructor Profile:
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 6 years ago, has served consumer products and FDA-regulated
industries with training and troubleshooting expertise covering water systems, sterilization, aseptic process-
ing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. He
has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time con-
sulting, he had 25 years of diverse "Big Pharma" operating company experience with Pfizer, Burroughs
Wellcome/Glaxo Wellcome, DSM and others.
Registration Information:
* Register Online. Use your American Express, Visa or MasterCard.
* For more than one attendee get 20% off on the price of additional attendee.
* Get your group to attend the webinar at a discounted price call +1- 650-620-3937.
* Call +1 - 650-620-3937 or Fax your PO: 650-963-2556.
* Mail your check to: ComplianceOnline (MetricStream, Inc), 2600 E. Bayshore Road, Palo Alto, CA 94303.
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