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Quality by Design: Next Steps to Realize Opportunities? - page 2 / 37

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Outline

“Quality by Design” (QbD)

What is QbD from a pharmaceutical science perspective?

How is/should QbD be achieved?

When is/should QbD achieved?

How is/should level of QbD be evaluate and measured?

How should QbD communicated?

What is the relationship between QbD and Risk?

What are/should be the regulatory benefits of QbD?

What steps should FDA take to realize the benefits of QbD?

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