1. Lesson 8: BRITE Seminar: GMP II
Jenae Williams - Learning Consultant

2. Regulatory Affairs
Liaison for all internal and external regulatory functions
Provides change control guidance for documents, process, equipment and facilities.
Guide and supervise all regulatory submissions for specific products

3. Regulatory Affairs Coordinate and refine regulatory strategy for:
Product development
FDA submissions
Compliance issues
Assess and exercise good judgement in interpreting and implementing governmental regulations and procedures
Assure standards of content and format of FDA submissions

4. Regulatory Affairs Provide regulatory guidance to internal personnel
Build and maintain excellent relationships with FDA personnel
Responsible for accuracy and content of communications with FDA and other international agencies

5. Manufacturing Function and Roles
Support Roles:
Quality Assurance Function and Roles
Corporate Quality Assurance Function and Roles
Quality Control Function and Roles
FUME Function and Roles
Supply Chain Function and Roles
Regulatory Function and Roles
Technology Development Function and Roles
Research and Development Function and Roles
Medical and Clinical Research Function and Roles

6. Quiz Review Quality Control (QC)
Facility Utilities Maintenance and Engineering (FUME)
Supply Chain
Regulatory Affairs