Using Quality Tools from Ideation to Development

Presented by Amy L Lachapelle and Bill Hackett, QBD Strategies LLC The value stream that moves biologics and pharmaceuticals from product ideation to product development and eventually to market can benefit from tools known to quality professionals for decades. Attendees will identify and apply the seven basic quality tools and perform activities that will enable them to apply the quality tools to their own professional endeavors. This will ensure better data integrity, communication, and a smoother flow between process steps in product development leading to commercialization. The discussion and activities will focus on utilizing a process approach in R&D with a focus on: Strategies to align research with product development The seven basic quality tools Brainstorming for product development Flow charts and your Target Product Profile Measures and metrics to ensure successful progress This is intended to be a highly interactive session in which we will brainstorm a new product then map a development process that will be a first iteration of the target product profile and your product development strategy. Attendees will learn about approaches to prioritizing research and projects based on need and risk. There will be discussions on identifying appropriate process inputs, measuring process outputs, and monitoring these against the product development strategy to assess progress and success.