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Course Name
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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
|