FDA’S ADVERSE EVENT REPORTING AND PRODUCT RECALLS

Description

This training program will provide the regulatory requirements for complaint handling in the pharmaceutical & medical device industries. The course will touch on complaint sources and details will be furnished on the interrelationships regarding complaint handling and product recalls. The course will also include timeline requirements associated with adverse event reporting.

This webinar will describe the key elements and requirements for a compliant system and a system for conducting recalls. Anyone in the pharma or FDA regulated industries must attend. You will learn how to electronically submit and manage your adverse event reports which should be integrated with a complaints management system. This will assist you to centrally manage and control your adverse event reporting. In this webinar, you gain a clear understanding of what FDA inspectors look for when evaluating complaint handling and medical device reporting programs.

Objectives of the Presentation:

• Understand what complaints and recalls are
• What are the FDA requirements for complaints, adverse events and recalls
• What are the documentation requirements
• What are the reporting requirements
• Requirements for a complaint system
• Reporting adverse events
• Requirements for a recall system

Areas Covered in the Session :

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

Who Should Attend:

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