GMP Complaint Systems, FDA's Adverse Event Reporting & Product Recalls
Duration : 75 Minutes
Joy L. McElroy,
Joy McElroy entered the pharmaceutical industry in 1992 shortly after earning a Bachelor of Science degree at North Carolina State University. She began at Pharmacia & UpJohn performing environmental monitoring and sterility testing. From there she moved into a supervisory role at Abbott Labor Read more
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.
Course Objectives:
• 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
Why Should You Attend:
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.
Course Outline:
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Those working in the FDA compliant industries such as pharma, medical devices and biotech:
• Regulatory compliance professionals
• Quality assurance professionals
• Quality control professionals
• Regulatory affairs professionals
• Complaint handling professionals
• Quality engineers
• Service technicians and engineers
• Manufacturing and design engineers
• Process development personnel
• Senior management
• Quality assurance/control
• Production personnel
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
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