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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.
Speakers:
Amy LaChapelle, MS
Amy has 16+ years’ experience in the biotechnology industry working in the areas of protein replacement therapies, gene therapies, and analytical methods development. As Director of Protein Services at GlycoSolutions Corporation, she was actively involved in continually improving their cGMP quality systems and processes. She has experience with control of monitoring and measuring of equipment and processes, verification, and validation activities. She is a certified internal quality auditor with a BS in Biochemistry and a MS in Applied Mathematics.
Bill Hackett
Bill has 25+ years’ experience in quality management development and implementation for ISO and AS9100. He has served as quality manager for Saint-Gobain Research and Development, Lockheed-Martin as a quality consultant to the Engineering Services division of the Federal Aviation Administration, and quality manager to electronic manufacturers and health-care providers. Bill is proficient in developing quality manuals and training materials and is an Exemplar Global certified principal auditor and instructor. He has a BS in Natural Science, and MEd in Natural Science and an MA in psychology.
Our mission is to facilitate and assist the creation, growth, and success of the next generation of biotech companies. We were created to nurture entrepreneurial and economic development in the community. We aim to do this by maintaining affordable lab and office space and making cutting-edge technology, services, training, mentoring, and a network of professional advisors available to small biotechnology companies and heath-related start-ups.
Now open for business. Accepting applications now.
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