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FDA COMPLIANCE & ENFORCEMENT
INSPECTIONS
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- ♦ SOPs
♦ Training
♦ Audits
♦ Handling During Inspections
♦ Responding to FDA Inspectional Observations (483s)
- ♦ Strategy and Remediation Implementation
♦ Drafting
♦ Liaison with FDA to ensure Close-out
- ♦ Import Detentions
♦ Seizures
♦ Injunctions and Consent Decrees
♦ Criminal Prosecutions
♦ Application Integrity Policy
- ♦ Conducting
♦ Report Preparation
- ♦ Assessing need for recall
♦ Implementation
• Risk classification process
• Logistics
♦ Managing Products Liability Risks
- ♦ SOPs –
• drafting
• review
♦ Compliance
• audits
• training
♦ Financial Disclosure Requirements – Compliance and Strategies
• Federal: FDA & HHS
• Institutional (e.g., university, hospital)
• Clinical trial design to minimize conflicts
♦ State regulatory requirements
To see presentations and articles on Compliance & Enforcement , click here ...
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