ON-DEMAND WEBINAR
Mastering Analytical Development: Implementing DOE for the ICH Q14 Enhanced Approach
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.
This video covers:
- Understanding ICH regulations: Gain an understanding of the latest ICH Q14 guidance and application of the enhanced approach to determine method operational design regions (MODRs) and proven acceptable ranges (PARs) for analytical procedure parameters.
- Implementing DOE: Learn how interactive DOE tools can be used to design and analyze multivariate experiments to satisfy the latest guidance for analytical procedure development.
- Overcoming common challenges: Discover the tools to lower the barrier of entry to DOE and quickly implement multivariate experiments to get products to market faster.
About the Presenters
Andrea Coombs, Principal Systems Engineer
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, Principal Systems Engineer
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.