200501PDAWestCoast.pptVIP

Agenda 1. History 2. Compliance Tool 3. Preamble 4. Key Points 5. System Design 6. Personnel 7. Process Simulation Studies 8. Survey History of Guidance Document Previous Document, 1987 Early Draft Public, 1997 PDA Points to Consider, 8/00 - 2/02 PQRI, 3/03 FDA Draft Guidance, 8/03 PDA Comment, 11/03 FDA Final Guidance Document, 9/04 PDA Input Received by FDA PDA’s Points to Consider 37 are aligned 5 are partially aligned 1 not aligned 6 are not addressed All PQRI Recommendations were Adopted PDA made 100 Comments 39 were adopted 19 alternates were adopted 52 were rejected Other Public Co