Water System Compliance - What Makes Water Systems Have Microbial Quality Problems

Instructor: T.C Soli
Product ID: 701283
Training Level: Intermediate
  • Duration: 90 Min
This Water System Compliance training will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Apr-2009

Training CD / USB Drive

$500.00 (30%)
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(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

Most people who design, maintain, and monitor high purity water systems have heard of biofilm and a few "rules" about how to control and monitor it. Unfortunately, many of these "rules" such as flow rates, dead legs, surface smoothness and the like are either only half right or frankly wrong. Once there is an understanding of the basics of how biofilm really develops on surfaces and how that protects it, it is easier to see how it can impact the operability of various unit operations in a water system and why it is so hard to control and even to monitor accurately.

This presentation will review what biofilm is and how it grows and will cover how it affects just about every kind of unit operation used in today's water systems. It will also cover the various principles or "rules" now used and why they may be mis-applied and often inappropriate, as well as what kinds of approaches do work to control it and monitor it. This presentation is also intended to be interactive to the extent that your specific questions can also be addressed if they haven't already been covered by the presentation.

  • Poor microbial control in water systems is usually caused by a poor understanding of biofilm.
  • Poor microbial control in water systems is usually related to poor system design, poor maintenance practices or poor process control levels that allow biofilm development.
  • Poor microbial control in water systems will eventually lead to process or product microbial contamination, that may in turn lead to high product reject rates, product recalls, regulatory scrutiny, and financial losses due to potential injury litigation and damaged company image.
  • Costly system design features may be well in excess of what is needed to adequately control biofilm development.
  • Cheaply constructed water systems are probably more costly than more expensive water systems in the cost of ongoing maintenance, excursion investigations, and product losses.

Areas Covered in the seminar:

  • Understand biofilm basics and how it develops.
  • Understand the impact of biofilm on the commonly used purification unit operations.
  • Understand how various commonly used microbial control strategies work (or don’t work) to control biofilm development.
  • Understand the how, where, and why of microbial monitoring, action levels, etc.
  • Debunk a few water system microbial control myths.
  • Get answers to your own water system questions.

Who will benefit:

This webinar will be valuable for all companies that operate high purity 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:

  • Engineers involved in water system design.
  • Utility operators and their managers involved in maintaining water systems.
  • QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels.
  • 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.
  • Validation managers and personnel.
  • Consultants and troubleshooters.

Instructor Profile:

T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and has been consulting full time for 5 years, serving consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, and microbiological laboratory operations. Prior to consulting, he had 25 years of diverse "Big Pharma" operating company experience.

During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.

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Effective Quality Oversight of Pharmaceutical Contract Manufacturing Organizations (CMOs)

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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