Quality by Design

Thursday, May 1 – Friday, May 2 2014
8:30 am – 4:00 pm

This event was posted by Worcester Polytechnic Institute

Event Inquiries

Jody Reis, jreis@wpi.edu 508-831-4163 http://cpe.wpi.edu/quality-by-design.html

Location: Worcester Polytechnic Institute

The FDA requires all companies that produce live culture drug products to comply with GMP (Good Manufacturing Practices) in order to mitigate risks associated with the manufacture of these products. Quality by Design principles (QbD) are encouraged by the FDA as an important component of process design validation, ensuring processes reflect a clear understanding of the science, technology and risk associated with drug manufacturing.

WPI’s Quality by Design program covers the principles of QbD and how to apply them to real life design problems. The program complements our Cleaning Validation training. Companies who are currently engaged in live culture biomanufacturing, or would like to move into this arena, should ensure their employees are trained in QbD.             

Key Learning Objectives

  • Understand risk-based GMP compliance and FDA, ICH and ASTM approaches
  • Review strategies for defining risk, risk factors and risk prioritization
  • Understand the basic fundamentals and approach of QbD
  • Learn to use Design of Experiments (DoE) to provide regulatory flexibility for specification setting and post-approval changes
  • Use QbD to mitigate product risk in engineering drug manufacturing operations
  • Understand the connection between QbD and Process Analytical Technology (PAT)
  • Implement the concept of Innovation and Continuous Improvement throughout the product life cycle

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