The FDA Inspection: Best Practices for Preparation, Behavior, and Response
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.Areas CoveredTypes of InspectionsPreparation - Dedicated personnel for inspection - Facility resources to support the inspection - Internal auditsSOP for inspections Behavior during an inspection: What to say and do, and what not to say and doInspection process How and when to craft a written responseWho Should AttendThis webinar will provide valuable assistance to all regulated companies since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical and Biologics fields. The employees who will benefit include:Quality AuditorsCompliance Officers Executive ManagementManagers/Directors/Supervisors and Personnel related to: - Regulatory Compliance and Regulatory Affairs - Quality Management System - Quality Assurance - Product Development - Engineering - ManufacturingComplaint HandlingPersonnel new to the regulated industryTraining personnel Document Control PersonnelWhy Should You AttendThe FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and now you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's your compnay! However, adequate planning, training, composure, and understanding should result in many encore presentations!
Single
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of the FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Areas Covered
- Types of Inspections
- Preparation
- Dedicated personnel for inspection
- Facility resources to support the inspection
- Internal audits - SOP for inspections
- Behavior during an inspection: What to say and do, and what not to say and do
- Inspection process
- How and when to craft a written response
Who Should Attend
This webinar will provide valuable assistance to all regulated companies since FDA inspects across the Medical Device, Diagnostic, Pharmaceutical and Biologics fields. The employees who will benefit include:
- Quality Auditors
- Compliance Officers
- Executive Management
- Managers/Directors/Supervisors and Personnel related to:
- Regulatory Compliance and Regulatory Affairs
- Quality Management System
- Quality Assurance
- Product Development
- Engineering
- Manufacturing - Complaint Handling
- Personnel new to the regulated industry
- Training personnel
- Document Control Personnel
Why Should You Attend
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and now you're in the spotlight, and if your performance isn't good, it's not the show that may close, it's your compnay! However, adequate planning, training, composure, and understanding should result in many encore presentations!