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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GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Agenda is subject to change.

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