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If done using a one-size-fits-all template, it probably satisfies regulatory requirements but is indeed a waste of time when it could be a valuable "insurance policy". All water systems are different and have different challenges in consistently purifying and delivering acceptable water to users. Therefore, the validation details used for every water system should probably be unique, making a standard template convenient, but inappropriate. Using a little common sense and knowledge of how the water system works and is maintained, the thoughtful validation of a water system can be very worthwhile. This presentation will cover the basic ground rules you should have in place before embarking on water system validation, how that validation should be customized to your particular water system design and maintenance practices, what operational elements should be included in the validation based on potential impact, what happens when the "honeymoon" is over and the system ages, and at what point is validation finally over. Because of water system and validation costs, packaged water options are sometimes considered, but additional costly issues for packaged waters may not have been considered, as will be discussed. Also discussed will be lab water systems that may have special validation needs different from production's water systems.
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.
Areas Covered in the Session:
- 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?
Who Will Benefit: This webinar will be valuable for all companies that operate non-compendial deionized water systems as well as WFI or Purified Water systems, particularly for those in FDA and EMA regulated industries, including Medical Devices, Diagnostics, Pharmaceutical APIs and Dosage Forms, Biologics, consumer products, and cosmetics companies. The specific job functions that 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