How FDA Trains Its Investigators to Review Sub-Systems for State of Compliance: What You Need to Do to Prepare for a Successful Inspection 2016

Key Topics

• 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

Who should Attend

• 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