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MEDICAL DEVIES

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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