ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
Manufacturing Subcommittee
CDER Advisory Committee Conference Room
AGENDA
Agenda:
Conflict of
Interest
9:00 PQRI/FDA Workshop Report Summary Tobias Massa, Ph.D.
Assessing
"Quality by Design" Norman Schmuff, Ph.D.
Industry - PhRMA Gerry
Migliaccio
- GPhA Gordon
Johnston
Academic Kenneth
Morris, Ph.D.
Regulatory - GMP Joe
Famulare
- CMC Ajaz
Hussain, Ph.D.
CMC: Specifications and
Post-Approval Changes Colin Gardner,
Ph.D.
GMP: Greg
Guyer, Ph.D.