Water System Compliance - Implementing Changes to a Validated System

After initial qualification, few water systems remain unchanged for long. Old seals need to be replaced, valves begin to leak and need to be replaced or refurbished, pumps eventually fail and must be replaced, outlets need to be added or removed, loops need to be expanded, water production capacity needs to be increased, and so forth. All these changes have the capability of compromising the validated state of the water system, so they must be carefully executed and the changes assessed for impact, i.e. qualified. A major system revalidation is often an unnecessary over-reaction to minor changes mandated by well-meaning folks who don't understand the microbiological risks of the proposed changes.

When overly conservative validation or change control departments take this stance, needed maintenance and component replacements tend to be put off and may eventually become major system or even product compromising issues. By the opposite token, looser change control programs may rely on the judgment of utility personnel who don't understand the microbiological risks as to what kinds of changes are minor and may not require any kind of qualification and minimal, if any, change documentation. Both extremes are highly undesirable, so this presentation focuses when such changes truly require a major or minor qualification effort and when it is safe to use the water again through a better understanding of quality specifications and process control levels, as well as the microbiology of water systems.

Areas Covered in the seminar:

• Water process control levels and quality specifications and how they differ.
• Purpose of a Change Control program – a help, not a hindrance.
• When is a change major vs. minor, requiring full vs. limited re-qualification?
• What about water use during re-qualifications?
• FDA validation expectations.
• Reliance on logic and common sense and the disservice of precedent and paradigms.

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:

• 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.
• Validation managers and personnel.
• Consultants

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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