FDA’s Adverse Event Reporting and Product Recalls 2018

Topics

• GMP standards for an effective recall system
• GMP requirements for complaint documentation and management
• To understand the specific requirements for organization, procedures and resources
• To identify the key issues in product complaint and recall handling
• Best practices related to documentation, management and regulatory reporting
• How the FDA responds to adverse event reports and the regulatory consequences for not reporting
• To understand and develop actions to resolve current issues applicable to you

Who should Attend

• Quality Control Departments
• Quality Assurance Departments
• Compliance Departments
• Regulatory Affairs Departments
• Complaint Handling Professionals
• Manufacturing Departments
• Production Departments
• Engineering Departments
• Operations Departments
• Service Technicians
• Process Development Professionals
• Design Assurance Teams