How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection

The How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection covers topics such as:

  • Warning Letter and Notice of Violation Responses/Communicating with FDA
    • Drafting
    • Strategy and Remediation Implementation
    • Effective Responses
    • Liaison with FDA to ensure Close-out
  • FDA History, Inspectional Strategy and Techniques
    • Training
    • SOPs
    • Managing the Inspection and State of Readiness
    • Audits
    • Mock Inspections
    • Responding to FDA Inspectional Observations (483s)/Warning Letters
    • IOM (Investigations Operations Manual)
    • Compliance Program 7356.002, Drug Manufacturing Inspections and other Compliance Programs Device Manufacturing Inspections
    • Field Management Directives
    • RPM (Regulatory Procedures Manual)
    • Inspection Technical Guides and official documents used as reference material for investigators and other FDA personnel
  • State of Readiness/Practice/Mock Inspections
    • Practice Sessions and Dress Rehearsals on Day Two
    • Prepare for "real" inspections by being ready and not caught off guard

The How FDA Trains Its Investigators and Inspectors to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection brings together:

  • Individuals who come in contact with regulatory inspectors
  • Managers responsible for GMP/GLP/GCP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm`s operations and monitoring of their state of GMP compliance
  • Compliance/Regulatory affairs Professionals
  • Auditors
  • Senior Management Executives (CEO, COO, CFO, etc.)
  • QA/QC Professionals
  • Project Managers
  • Manufacturing Managers, Supervisors & Personnel
  • Regulatory Affairs Specialist
  • Regulatory Affairs Management
  • Compliance Officer
  • Auditors
  • Clinical Affairs
  • Compliance Specialist
  • Marketing & Sales
  • Quality Assurance Management
  • Legal Counsel
  • Distributors/Authorized Representatives
  • Operations/Manufacturing
  • Engineering/Technical Services
  • Consultants

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