Make Quality by Design a Practical Reality

According to the FDA, Quality by Design (QbD) is a “scientific, risk-based, holistic approach to pharmaceutical development” that involves a “deliberate design effort from product conception through commercialization.” Use of QbD in pharmaceutical manufacturing yields substantial business benefits, including:

• Reduced operating costs
• More efficient manufacturing processes
• Better positioning to meet regulatory requirements

In addition to these benefits, recent regulatory developments suggest a push toward QbD – for instance, the FDA recently suggested that all Abbreviated New Drug Applications (ANDAs) for generic drugs should have QbD elements. How can your company turn Quality by Design into a practical reality? ISPE’s QbD Training Course provides an in-depth explanation of product and process development using Quality by Design methods. Through group exercises, in-depth discussion, and real-life examples, you’ll learn how to effectively implement this manufacturing strategy. ISPE training courses are led by internationally recognized experts and carefully designed for you. Our course instructors deliver the kind of training that will yield visible results for you upon returning to work. By the end of our Quality by Design Course, you’ll be able to:

• Understand QbD terminology, including science- and risk-based approaches, product and process understanding, and patient requirements
• Use tools and techniques provided to understand the application of Quality Risk Management (QRM)
• Know the relationship between PQS and GMP and how they link to Control Strategy
• Examine opportunities for continuous improvement arising from application of statistical techniques
• And more

Interested in learning more about Quality by Design? ISPE’s next QbD course takes place 23 – 24 May in Tampa, Florida.