Logical Water System Validation

Speaker

Instructor: T.C Soli
Product ID: 701358

Location
  • Duration: 90 Min
This Water system validation training will guide you on 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.
RECORDED TRAINING
Last Recorded Date: Oct-2012

 

$229.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$299.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

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.

Areas Covered in the Seminar:

  • Why validate a water system?
  • What you should know and do before you validate?
  • Figuring out what you should validate?
  • Validation elements and phases.
  • Minimum validation expectations.
  • What happens after the honeymoon is over?
  • Is validation ever really over?
  • Special considerations for lab water systems.
  • Packaged water options.
  • Pure Steam specification & validation considerations.
  • Pure Steam testing & troubleshooting considerations.

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:

Dr. Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE’s Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method