FDA Adverse Event Reporting
Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their 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 14 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, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize.
Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries. Joy specializes in Equipment Qualification, Sterilization, Cleaning Validation, and GMP Compliance Auditing.
In 2013 Joy started her own company, Maynard Consulting Company, which provides top engineers, auditors, and validation specialist to pharmaceutical, biotech and medical device clients across the United States, Canada, and the world.
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.
- 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
- 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
Why Should 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.