|
Date |
Title |
Occasion/Speaker |
| |
|
|
|
November, 2004 |
Comparability Protocols: FDA
Perspective [HTML] or [PPT] |
2004
AAPS Annual Meeting/Stephen Moore |
| November, 2002 |
Post Approval
Changes for Bulk Drug Manufacturing — Status Report [HTML]
or [PPT] |
Nov 2002
AAPS Annual Meeting /John Smith |
| June 2002 |
HOT ISSUES
Encountered While Drafting the FDA Drug Substance Guidance [HTML]
or [PPT] |
June
2002 DIA Annual Meeting in Chicago/John Smith |
| November, 2001 |
Pharmaceutical
Drug Packaging |
The Society of the
Plastics Industry Inc., Charleston, SC/ Donald Klein |
| October, 2001 |
1987
Drug Substance Guideline Revision |
DIA Conference,
Washington DC/ John Smith |
| May, 2001 |
Stability
Data File |
DIA Data Standards, Washington, DC/
Jon Clark |
| January, 2001 |
Presentations and software
demonstrations as follows: |
Electronic IND Public Meeting, Rockville
MD/ |
| Life
Cycle Management |
Steven Koepke |
| CTOC
Model Slides |
Jon Clark |
Three
Hyperlinks:
FDA Position Statement
CTOC XML Tool Download
Link Validation Tool |
Naiqi Ya |
| October, 2000 |
Product Quality, and Chemistry, Manufacturing and Controls Reviews |
AAPS Annual Meeting and Exposition,
Indianapolis IN /Hasmukh Patel |
| October, 2000 |
Seven sets of slides were presented as follows: |
PhRMA/ONDC
Dialog Session, Rockville MD/ |
| Risk-Based CMC Review: |
Yuan-yuan
Chiu |
| ICH Guidances Implementation Consistency: |
Chuck
Hoiberg |
| Guidance and Regs Status: |
Hasmukh
Patel |
| Electronic CMC Submissions: |
Jon
Clark |
| Division vs. Field Responsibilities: |
Chuck
Hoiberg |
| Drug Supply Shortage Group: |
Eric
Duffy |
| Pre-NDA Meetings: |
Steve
Koepke |
| September, 2000 |
Role
of ONDC in CDER's Mission |
OTCOM
Reviewer Training, Rockville, MD/
Shelly Markofsky,
Hasmukh Patel,
Bonnie Dunn |
| June, 2000 |
Packaging
Post Approval Changes (PACPAC) |
AMPAC/PACPAC
Workshop, Crystal City, VA /Don Klein |
| May, 2000 |
History
of SUPAC Comparison of SUPAC IR,MR,SS |
FDA/ISPE
SUPAC Idustry Exchange, Providence, RI /Bonnie Dunn |
| May, 2000 |
Pharmaceutical Solids |
SSCI
Solids Course, Crystal City, VA /Chuck Hoiberg |
| January, 2000 |
ICH
Update - Quality |
Class
Conference, San Francisco /Yuan-yuan Chiu |
| October, 1999 |
Container/Closure
Guidance,
four presentations:
Guidance Introduction
Guidance Overview
Type III DMF
Bulk Containers |
FDA/Industry Container Closure Guidance Training Session, Rockville/
John Smith
Donald Klein
James Vidra
Melissa Maust |
| October, 1999 |
FDA
Perspectives on Manufacture of Single Enantiomer Drugs |
"45th
International Conference on Analytical Sciences and Spectroscopy" Vancouver, Canada/Steve
Miller |
| September, 1999 |
Guidance for
Industry Container Closure Systems for Packaging Human Drugs and Biologics |
1999 PDA FDA Joint Conference
&Courses: New FDA Packaging Guidelines/Donald
Klein |
| August, 1999 |
The Impact of Polymorphism on Drug Development:
A Regulator's Viewpoint Separate Text Notes: MSWord |
XVIIIth Congress of the International Union of Crystallography at Glasgow,
Scotland/Wilson DeCamp |
| August, 1999 |
Quality
Control and Quality Assurance of Botanicals |
Complementary and
Alternative Medicine in Chronic Liver Disease, NIH, Rockville /Yuan-yuan Chiu |
| July, 1999 |
Regulatory Issues in the Photostability of Topical Drug Products |
Annual Meeting, American
Society of Photobiology, Washington DC/William Timmer |
| July, 1999 |
CMC Electronic Submissions |
DIA Annual Meeting, Baltimore/Jon Clark |
