Risk-based change classification, assessing regulatory filing impact, and where ICH Q12's established conditions concept fits in.
This course covers the change control lifecycle from proposal through implementation and effectiveness review, risk-based classification of changes and how it determines the level of review required, how to assess whether a change triggers a regulatory filing obligation, and where ICH Q12's established conditions concept intersects with change classification.
A change that should have triggered a regulatory filing but did not is one of the more serious findings a site can face, since it calls into question whether the approved process is actually what's being run. Getting classification right at the proposal stage prevents that outcome entirely.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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