September 25 & 26, 2017
Incorporating lifecycle and QbD perspectives into bioassays is gaining traction and recognition as legitimate practice in the industry. USP’s 7th Bioassay Workshop will give attendees the opportunity to consider and discuss lifecycle methods from scientific, statistical, and regulatory perspectives, including the presentation of case studies from various stages in an assay’s lifecycle. The role and requirements of the bioassay shift as a product emerges from research and evolves through development and commercialization. Decisions are made throughout the lifecycle of the bioassay using sound scientific principles and appropriate statistical approaches to understand the impact and risks of specific choices in assay design and development, qualification, and continued performance verification, including bioassay transfer, maintenance, updating, and retirement. A key element of the workshop will be expounding on lifecycle-oriented ideas already present in USP bioassay chapters.
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