FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Up | AC Home Page

Food and Drug Administration

Center for Drug Evaluation and Research

Pharmaceutical Science (ACPS) 

October 05, 2006



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)

Up | AC Home Page

Page last updated October 23, 2006 kkhorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management