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Session 25: Regulatory Compliance and FDA Inspections: What To Expect After Submitting the NDA
Session Chair(s)
Michael Hamrell, PHD, RAC
President
MORIAH Consultants, United States
- GLP Inspections
- GCP Inspections
- Inspection Outcomes: Additional Considerations in GCP Inspections
- GMP Inspections
- Inspection Outcomes (GLPs, GCPs, GMPs)
- FDA Enforcement Actions
- Application Integrity Policy (AIP)