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Beschreibung

"Pharmaceutical water systems must be appropriately designed, operated, and maintained in order to produce high quality water. USP General Chapter <1231> Water for Pharmaceutical Purposes provides detailed information about nearly every aspect of maintaining, validating, and monitoring a pharmaceutical water system. Validation is the process to demonstrate that the design and operation of a pharmaceutical water system consistently produces water that meets USP requirements. General Chapter <1231> provides extensive discussion of the life cycle elements to maintain a validated state of control. This webinar specifically addresses validation and qualification approaches, including design and operation, water sampling purposes and procedures, the “trigger levels"" associated with test results, and microbial identification. Other elements of USP Chapter <1231> will be discussed in future webinars. The instructor, Mr. Rosty Slabicky has been involved in developing the contemporary pharmaceutical water standards and associated with USP for over 25 years as an advisor and USP Pharmaceutical Waters expert during three consecutive cycles as a volunteer."