Center
for Drug Evaluation and Research
Pharmaceutical
Science (ACPS)
October
05, 2006
Slides
Disclaimer
The statements
contained in this document(s) are those of the product's
sponsor, not FDA, and FDA does not necessarily agree with
the sponsor's statements. FDA has not made a final determination
about the safety or effectiveness of the product described
in this document.
Topic
I: International Conference Harmonisation (ICH)
Quality Topics Update
Topic Introduction,
Moheb Nasr, Ph.D., FDA (htm)
(ppt)
Q8-Pharmaceutical
Development, John Berridge, Ph.D., Pfizer (htm)
(ppt)
Q9-Quality Risk
Management, H. Gregg Claycamp, Ph.D., FDA (htm)
(ppt)
Q10-Pharmaceutical
Quality Systems, Joseph Famulare, Office of Compliance,
FDA (htm) (ppt)
Q4B-Regulatory Acceptance
of Analytical Procedures and /or Acceptance Criteria, Robert
H. King, Sr., FDA (htm) (ppt)
Open
Public Hearing
Pharmaceutical Quality
by Design: A PAT Equipment Vendor Certification Proposal,
Charles P. Hoiberg, Ph.D. & Neil Lewis, Ph.D. (htm)
(ppt)
Quality Systems
and Risk Management (Q9 & Q10), Frederick Razzaghi.
(htm) (ppt)
Topic II:
Implementing Quality-by-Design
Topic Introduction
and an FDA Perspective, Moheb Nasr, Ph.D., FDA (htm)
(ppt)
ONDQA Initiatives,
Chi-Wan Chen, Ph.D., FDA (htm)
(ppt)
Office of Generic
Drugs Initiatives (OGD), Lawrence
Yu, Ph.D., FDA (htm) (ppt)
Office of Biotechnology
Products (OBP) Initiatives, Steven Kozlowski, M.D., FDA
(htm) (ppt)
Generic Pharmaceutical
Association (GPhA) Perspectives, Gordon Johnston, R.Ph,
M.S., Pfizer (htm) (ppt)
Progress on Quality
by Design A PhRMA Perspective, Robert G. Baum, Ph.D., Pfizer (htm) (ppt)
