GXP

Changing the Change Process | IVT

The following is a summary of the proceedings with editorial notes and commentary. Twelve speakers provided many common themes. Where there was a common message from more than one speaker, that thought is combined without reference to the contributors. Where a recommendation can be attributed to a specific speaker, that speaker is referenced, keyed to the Agenda in Figure 5. Since this meeting was organized by CDER, it focused on drug products. There was a troublesome exclusion of references to changes to biological products covered under 21 Code of Federal Regulations (CFR) 601.12,2 with the...

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