Description:

Water systems are among the most scrutinized areas in any FDA or GMP inspection, and for good reason. Knowledge of water microbiology is critical to every facility producing a pharmaceutical or biotechnology product, and even companies manufacturing tablets need to be aware of the quality of water contacting their process or product. A single microbiological excursion in your purified water, WFI, or steam system can trigger an investigation, halt production, and in serious cases force a facility-wide shutdown lasting weeks. Regulators at the FDA and global agencies, including USP, EP, and JP, have clear and specific expectations for how pharmaceutical water systems are designed, tested, monitored, and validated, and the Warning Letters issued to companies that fall short are a sobering reminder of what is at stake.

This instructor-led training session takes a comprehensive and practical look at the key issues surrounding water systems in a GMP facility, from testing each water source and commissioning requirements, to risk management approaches and how a well-developed Facility Water Validation Plan can logically reduce your testing burden over time. Whether you are setting up a new water system, troubleshooting an existing one, or preparing for an upcoming inspection, attendees will gain the regulatory grounding and practical tools needed to maintain control over potable water, purified water, WFI, and steam, ensuring full compliance with USP, EP, JP, and FDA standards and keeping your facility audit-ready.

Learning Benefits:-

• How to set up a water sampling system and determine test frequency.
• Assessing the “health” of a water system from test results.
• Differences between USP, EP, and JP water requirements.
• Understanding Alert and Action Levels vs. Specifications.
• When microorganisms should be identified and the preferred methods.
• Requirements for in-house vs. purchased water.
• Validations needed for Purified Water and WFI systems.
• Diagnosing and controlling water system problems.

Who Should Attend?

• Quality Assurance Personnel
• Quality Control Personnel
• Regulatory Compliance
• Facilities Staff
• Manufacturing Professionals
• Project Development & Management