FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
CENTER FOR BIOLOGICS EVALUATION AND RESEARCH
OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT
DIVISION OF MANUFACTURERS ASSISTANCE AND TRAINING
Effective Date: 07/08/2011
1. DIVISION OF MANUFACTURERS ASSISTANCE AND TRAINING (DKKBHB).
A. Provides assistance and training to industry, including large and small manufacturers and trade associations, and responds to requests for information regarding the CBER policies and procedures.
B. Informs industry and trade associations of the status of the CBER policies and initiatives through regular information mailings and training.
C. Communicates regularly with Center staff to insure they are kept informed of current CBER policies, procedures, initiatives, and accomplishments.
D. Serves as the CBER focal point for industry and trade associations to provide meeting support and coordinates external meetings with other FDA Centers.
E. Directs, manages, coordinates, and develops the Center’s overall professional and management training program, a formal career development program, a new employee orientation program, and related policies.
F. Coordinates and develops in-service and automated data processing (ADP) training programs pertinent and unique to the Center.
G. Coordinates with external organizations to develop and implement training, professional, and technical development programs.
H. Interacts with other FDA Centers and the Office of Regulatory Affairs in the development and implementation of scientific and professional training programs.
I. Participates as an active member of the CBER Curriculum Committees in the development and implementation of Centerwide scientific and professional training programs.
2. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Division were approved by the Secretary of the Department of Health and Human Services on July 8, 2011.