The course serves as a detailed overview of QbD, focused on current, state-of-the-art Analytical Methods as the target “Desired State.” The Critical Circle concept – zero-sum proportioning between Knowledge Base, Risk State and Desired State (key QbD aspects,) is applied to three principal instrumental methods. Manufacturing QbD aims at a Product Target Profile (PTP). For analytical methods, the Desired State becomes an Analytical Target Profile (ATP.) Course participants will evaluate both pathways and learn to adjust the Critical Circle accordingly.
The course content also includes a thorough grounding in Risk Management as defined and practiced in ICH Q9. The topics apply equally well to pharmaceutical, cosmetic, nutraceutical and food science applications.