FDA’s Adverse Event Reporting and Product Recalls

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

Course Director: JOY MCELROY

Upon earning a degree in Zoology at North Carolina State University, Joy began working in the pharmaceutical and biotech industries in 1992 at Pharmacia & UpJohn performing Environmental Monitoring and Sterility Testing. Her work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw the Quality Control Lab. In 1998 Joy moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, and holding annual GMP training for new employees. After working in Quality Assurance for a few years, Joy moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. With 19 years of experience as a consultant, and over 25 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Technical Writing, Process and Cleaning Validation, and Equipment Qualification and Computer System Validation and Part 11 Compliance. She has written and executed Equipment Qualifications and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Biotest, Novartis, Imprimis, Cody Laboratories, and Xceilence. Her knowledge, experience, have made her a highly sought-after engineer, technical writer, and trainer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Cleaning Validation, and GMP Compliance Auditing, and technical writing, and GMP, Audit Preparation, and SOP writing training, Computer System Validation and Part Compliance. In 2019 she opened her own company, McElroy Training and Consultancy, LLC which provides consultants for various projects as well as on and off – site training to pharmaceutical and biotech companies throughout the United States. Joy also spends her time mentoring and speaking as an Empowerment Speaker. Her goal is to empower people all over the world to live their dreams though implementing 5 simple techniques she has learned and applied through the years.