Logical Water System Validation

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:

• 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.

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