On-Demand Webinar

Managing Implementation and Regulatory Risks: Single Use Technologies for Final Fill

Duration: 1 Hour
Speakers: Jessica Shea, E&L Global Technical Services Manager, Provantage® Lab Services, Merck and Sue Walker, Market Development Manager, Final Fill, Merck

Abstract: The benefits of single use technologies are well documented. Risks associated with product loss, sterility and patient safety are magnified in the filling operation because of its closeness to the final product form and the patient. A systematic and thorough evaluation of the assembly manufacturing and filling process will identify risks that may be managed by the supplier and end user working together to create sound initial designs that are fit for the intended use. Managing regulatory and patient safety risks requires an accurate interpretation of regulatory requirements and the design of a step wise approach to identify and mitigate potentially toxic compounds that may leach from process components. This webinar will include remarks on key aspects of assembly manufacture and quality control; extractables and leachables, patient safety and implementation by the end user.

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