Course Name
|
Duration
|
Time
|
Major cGMP Compliance Courses
|
1:00pm - 4:00pm |
|
3 days
|
||
3 days
|
||
3 days
|
||
2 days
|
||
2 days
|
||
2 days
|
||
2 days
|
||
3 days
|
||
3 days
|
||
Other cGMP Compliance Courses
|
||
FDA cGMP Requirement: Buildings and Utilities
|
0.5 day
|
|
FDA cGMP Requirement: Development and Technology Transfer Reports
|
0.5 day
|
|
FDA cGMP Requirement: Documentation and SOPs
|
0.5 day
|
|
FDA cGMP Requirement: Change Control
|
0.5 day
|
|
FDA cGMP Requirement: Maintenance and Calibration
|
0.5 day
|
|
FDA cGMP Requirement: Product Annual Review
|
0.5 day
|
|
FDA cGMP Requirement: Label and Labeling Controls
|
0.5 day
|
|
FDA cGMP Requirement: Acceptance Criteria for Cleaning Validation
|
0.5 day
|
|
FDA International Inspection Program
|
0.5 day
|
|
Preparing for an FDA Pre-approval Inspection (PAI)
|
0.5 day
|
|
Preparation for and Handling of FDA Inspections
|
0.5 day
|
|
Other Courses
|
||
FDA Application Regulations: New Drugs and Generic Drugs
|
2 days
|
|
FDA Application Regulations: APIs
|
2 days
|
|
FDA cGLP Compliance: Interpretation and Application
|
2 days
|
|
FDA cGCP Compliance: Interpretation and Application
|
2 days
|
|
FDA: Design and Analysis of Clinical Trials
|
3 days
|
|
FDA: Fundamentals of Health Economics and Outcomes Research
|
2 days
|