Tracking and Trending Metrics in the Pharma and Biotech Industry

Statistical Process Control (SPC) & Process Capabilities

Regardless of how good your process is, there is always some variation. By monitoring the process over time, scientists and engineers can identify when the variation is becoming excessive and take steps to reduce it, so they can identify potential problems before they start affecting the product.

An important consideration in process monitoring is knowing when to react and how to differentiate the signals from the noise. Protecting product quality is central to the role of a process engineer/scientist, however, it is rare that there is only one source of variation that requires attention. Prioritizing process improvement projects using data-based risk metrics from process capability analysis reduces cost, and improves efficiency and product safety.

Learn how to:
  • Select between control chart types based on process performance
  • Set control limits, and when to update
  • Use process capability metrics to communicate the risk of OOS and to prioritize improvement projects

About the Presenters

Byron Wingerd, JMP Statistical Discovery

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.

Malcolm Stevens, JMP Statistical Discovery

Malcolm’s background in Biology and Education are key to his success in helping pharmaceutical companies implement data-driven strategies that improve performance. At JMP, he specifically helps companies in the health and life sciences industry use data to drive new discoveries, increase efficiency and communicate across functions to save time or improve processes or products.


This virtual webinar was moderated by Dr. Emily Frieben of Wiley. On-demand event now available courtesy of a joint partnership with Wiley. Visit WIley at

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