Established conditions, post-approval change management protocols, and how Q12 is intended to reduce regulatory filing burden.
This course covers what 'established conditions' means under ICH Q12 and how it is determined, post-approval change management protocols and how they reduce regulatory burden for pre-agreed changes, the product lifecycle management document concept Q12 introduces, and where Q12 adoption currently stands across major regulatory agencies.
Post-approval changes that should be routine often turn into lengthy regulatory filings because established conditions were never clearly defined at approval. Q12 exists specifically to fix that, but only for sites that build their submissions to take advantage of it.
Completion certificate, PDF slide download, and access to the complete GMP course library from day one.
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