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 2018 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 2018 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