PDA 399.1 Design, Operation, and Qualification of Pharmaceutical Water Systems

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This live eLearning training course provides a summary of compendial water systems from generation through storage and distribution. Feed water impurities and their impact on system design, operation, and maintenance will be discussed. The validation process is discussed from Validation Master Plan, URS, FRS, FMEA, IQ/OQ/PQ through long-term monitoring throughout the training course. Numerous case histories and “hands on” observations will be discussed to demonstrate proper design, operation, qualification, monitoring, and proactive preventative maintenance. A section of the training course will discuss non-distillation based Bulk Water for Injection Systems. The training course content will be valuable to any individuals interfacing with bulk compendial water systems from design, engineering, operation, manufacturing, Quality Assurance, compliance, maintenance, monitoring, and excursion evaluation.

Upon completion of this training course, the attendee will be able to:

  1. Evaluate the design of a compendial water system, considering feed water characteristics, from generation through storage and distribution
  2. Understand the importance of initiating system qualification throughout the design, engineering, risk assessment, installation, commissioning, protocol generation/execution, procedure preparation, monitoring program preparation, and proactive maintenance program
  3. Using exposure to both “hands-on” and case histories, understand the numerous potential pitfalls that should be addressed for compendial water systems
  4. Recognize the importance of system monitoring including sample collection, and analysis. For compendial water samples, understand the value of “delivered” water samples
  5. Understand the importance of a comprehensive proactive maintenance program in eliminating costly unplanned shutdowns

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