| |
|
|
| |
|
|
| |
HUM-MOLGEN
-> Events
-> Courses and Workshops |
|
|
| |
The Evolution of Drug Master Files (DMFs) | |
| |
March 07, 2007 |
|
|
| |
|
|
| |
|
|
|
Drug Information Association, Online
Mar 19 2007
Gain a Practical Understanding of the Contents, Formats, and Purpose of Drug Master Files (DMFs).FEATURED TOPICS
•Why DMFs?
•FDA-recognized types of DMFs
•CDER and CBER processes and review of DMFs
•Roles/responsibilities for DMF holders and those who reference DMFs
•Methods of change control
•Suggested formats for DMFs
•Traditional vs. electronic DMFs.
|
|
|
|
|
|
|
|
Organized by:
|
|
Drug Information Association |
|
|
Invited Speakers:
|
|
ARTHUR B. SHAW, P ARTHUR B. SHAW, PHD
Review Chemist and DMF Expert
Office of New Drug Quality Assessment
Division of Pharmaceutical Assessment 1
FDA.JOHN A ELTERMANN JR., RP JOHN A ELTERMANN JR., RPH
Director Division Manufacturing & Product
Quality CBER, FDA.
|
|
|
|
|
|
|
|
Deadline for Abstracts:
|
|
-
|
|
|
|
|
|
|
|
Registration:
|
|
http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f13870%2f07207.pdf
|
|
|
E-mail:
|
|
dia@diahome.org
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp,
Frank S.
Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved.
Liability, Copyright and Imprint. |
|