Explorers Series

Unearth the possibilities in your data

Lecture & Lunch

Building Process Knowledge and Boosting Quality with QbD Best Practices and Stability Analysis

Date: September 26, 2019
Time: 9:00 am - 1:00 pm
Location: Madison Concourse Hotel, 1 West Dayton St., Madison, WI 53703
Registration & Lunch: Free

Pharmaceutical companies today face significant pressure to build robust process development programs while simultaneously meeting the stringent requirements of regulatory agencies around the world.

Quality by Design (QbD) can help solve this challenge by providing a systematic approach for building quality directly into both the product and the process. Under the QbD paradigm, pharmaceutical quality is maximized while the risk of producing non-conforming batches is minimized. Quality is assured by using a strategy to develop process understanding and control of the manufacturing and formulation variables.

A well-designed control strategy relies both on process knowledge and continuous monitoring of the processes critical quality attributes. Process screening, custom design of experiments (DOE) and other comprehensive process monitoring techniques let you take control.

Furthermore, the quantitative analysis of stability data for product attributes can be used to define retest or shelf life estimation. And like QbD, stability analysis using regression or analysis of covariance to determine poolability and find the crossing time of the lower 95% confidence interval for the model are simplified with the right statistical software.

In this seminar, you will learn how to:

  • Apply the latest methods in definitive screening and experimental design to identify and optimize key process variables.
  • Enhance CPV activities using tracking and trending workflows to combine tables of specifications or control limits to generate robust and reproducible reports.
  • Use regression and ANCOVA methods to quickly generate stability reports and calculate crossing times.

Register now to attend in Madison.

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Rob Lievense
Rob Lievense

Rob Lievense is a JMP Senior Systems Engineer. A Six Sigma Black Belt, Lievense has more than 20 years of experience in the applied statistics industry. Prior to joining JMP, he served as Research Fellow of Global Statistics at Perrigo where he led a group that supported research and development in consumer health care.

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