Quality by Design using Design of Experiments (QbD) (Jun 12 - 13, 2017)

Quality by Design using Design of Experiments (QbD) is organized by GlobalCompliancePanel and would be held during Jun 12 - 13, 2017 at Mandarin Orchard Singapore, Singapore.

The target audience for this medical event are pharmaceutical and biopharmaceutical professionals who are involved with product and/or process design, validation, or manufacturing/control. This CME conference has been approved with 12 credits.

This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using Design of Experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product Quality System framework defined by requirements in regulatory guidance documents.

Areas Covered in the Session:
• Implement QbD principles from discovery through product discontinuation
• Apply statistics to set specifications and validate measurement systems (assays)
• Utilize risk management tools to identify and prioritize potential Critical Process Parameters
• Identify Critical Process Parameters and develop a functional relationship between those process parameters and your Critical-to-Quality Attributes (CQAs)
• Establish your design space
• Develop a control plan as part of a risk management strategy
• Ensure your process is in (statistical) control and capable.