Training
- Understanding and Interpreting FDA & Global Regulatory Requirements
- Quality System Requirements (FDA QSR, QSIT, ISO 13485, cGMP, GCP, GxP)
- Risk Management
- Design Controls
- Customer Complaints
- Medical Device Reporting
- Pharmacovigilance Reporting
- Corrections & Removals (Field Safety Corrective Actions)
- Corrective and Preventive Actions(CAPA)
- Management Responsibility
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