Quality by Design

Next Certificate program September 25-26, 2014

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

Benefits to employers and employees

  • be among the first to learn and implement these latest techniques for meeting FDA guidelines
  • produce a higher quality product more consistently and with less risk
  • waste fewer resources, achieve efficiencies
  • achieve compliance while reducing compliance costs
  • gain a higher ROI and competitive advantage as a result of the above

Program Logistics

Who should attend

Any employee working in a biotechnology facility that needs training in GMP, or will be moving into a field that must use GMP. This includes but is not limited to:

  • R&D scientists involved in process/product development and implementation
  • Process engineers and chemists working in development and operations
  • Pilot plan operations engineers and scientists
  • Quality assurance personnel
  • Technology transfer managers
  • Regulatory affairs personnel
  • Validation professionals
  • Personnel responsible for GMP compliance
  • Equipment sales representatives


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Raise your profits by 20%

Research by Ted Fuhr, Michele Holcomb, and Paul Rutten indicates that QbD raises profits by 20%. Read the paper Why quality-by-design should be on the executive team’s agenda.