Course Name
|
Duration
|
Time
|
Major QSR/cGMP Compliance and Regulatory Application Courses
|
9:00 - 12:00 13:00 - 16:00 |
|
FDA Application Regulations: Medical Devices |
2 days
|
|
FDA QSR/cGMP: Interpretation and Application |
3 days
|
|
FDA QSR/cGMP Compliance: Process Validation |
2 days
|
|
FDA QSR/cGMP Compliance: Design Control |
2 days
|
|
FDA QSR/cGMP Compliance: Corrective and Preventive Actions |
2 days
|
|
FDA QSR/cGMP Compliance: Auditing |
2 days
|
|
Computer System Validation and Part 11 |
3 days
|
|
Other QSR/cGMP Compliance Courses
|
||
FDA QSR/cGMP Requirement: Investigation and Handling of Deviations |
0.5 day
|
|
FDA QSR/cGMP Requirement: Documentation and SOPs |
0.5 day
|
|
FDA QSR/cGMP Requirement: Change Control |
0.5 day
|
|
FDA QSR/cGMP Requirement: Maintenance and Calibration |
0.5 day
|
|
FDA QSR/cGMP Requirement: Traceability and Tracking |
1 day
|
|
FDA International Inspection Program |
0.5 day
|
|
Preparation for and Handling of FDA Inspections |
0.5 day
|