Mastering Analytical Development: Implementing DOE for the ICH Q14 Enhanced Approach

In the ever-evolving pharmaceutical landscape, staying ahead of the curve in analytical development is critical. This insightful webinar guides you through the enhanced approach described in the recently updated ICH Q14 guidance and then demonstrates the tools needed to implement design and analysis of DOE. Our experts, Andrea Coombs and Byron Wingerd, delve into the latest industry standards and provide practical strategies to enhance your analytical development processes.

Whether you're a seasoned professional or new to the field, this session promises to offer valuable insights and tools to ensure compliance and drive innovation for analytical and process development teams alike.

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As a Principal Systems Engineer, Andrea Coombs supports customer development and sales for some of JMP’s biggest customers.

Andrea has more than 20 years of experience in applied analytics in several industries, including pharmaceutical manufacturing, pharmaceutical R&D, and agricultural research. She holds undergraduate and graduate degree in life sciences from Michigan State University.

Prior to joining JMP, Andrea served as Senior Industry Consultant for SAS, Senior Data Administrator for the American Board of Emergency Medicine, and Senior Manager of Manufacturing Science and Technology at Emergent Biosolutions.

Byron Wingerd helps people understand how to apply data science and statistics to learn more from their data to make better decisions in the life sciences space.

Before joining JMP, Byron worked in biologics manufacturing for the pharmaceutical industry. He was a Process Engineer for Merck in West Point, PA, and, earlier, a Senior Scientist at Emergent BioSolutions, where he was responsible for vaccine production and development. In that role, he used Six Sigma methodology for improving vaccine manufacturing processes. Byron also was the subject matter expert for the company’s BioThrax vaccine.