FDA COMPLIANCE & ENFORCEMENT
INSPECTIONS
    ♦  SOPs
    ♦  Training
    ♦  Audits
    ♦  Handling During Inspections
    ♦  Responding to FDA Inspectional Observations (483s)
WARNING LETTER AND NOTICE OF VIOLATION RESPONSES
    ♦  Strategy and Remediation Implementation
    ♦  Drafting
    ♦  Liaison with FDA to ensure Close-out
FORMAL ENFORCEMENT
    ♦  Import Detentions
    ♦  Seizures
    ♦  Injunctions and Consent Decrees
    ♦  Criminal Prosecutions
    ♦  Application Integrity Policy
INTERNAL CORPORATE INVESTIGATIONS
    ♦  Conducting
    ♦  Report Preparation
RECALLS
    ♦  Assessing need for recall
    ♦  Implementation
            • Risk classification process
            • Logistics
    ♦ Managing Products Liability Risks
GOOD CLINICAL PRACTICE (“GCP”) -- COMPLIANCE & TRAINING
    ♦  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


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© 2014  Michael A. Swit.  
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Michael A. Swit