FDA Adverse Event Reporting

Product Id IQW15C6127
Speaker Joy L. McElroy
Level Basic & Intermediate
Duration 90 Mins
  • Description
  • Why should you attend
  • Areas covered
  • Who will benefit
  • Speaker

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 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.

 

  • 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

 

  • 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

 

Upon earning a degree in Zoology at North Carolina State University, I began working in the pharmaceutical industry in 1992 at Pharmacia & Upjohn performing Environmental Monitoring and Sterility Testing.  My work allowed me to move into a supervisory role at Abbott Laboratories where I oversaw the Quality Control Lab. In 1998 I moved to Wyeth Lederle and worked in Quality Assurance, performing GMP Compliance audits, batch record reviews, holding annual GMP training for new employees, and writing audit report, and SOPs. After working in Quality Assurance for a few years, I moved into Equipment Qualification and Cleaning Validation at Mallinckrodt. 
With 12 years of experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, I have gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, and Technical writing. I have written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, and Phillips Medisize. I also develop and deliver webinars, on-site training, and seminars for training in areas such as Technical Writing, Equipment Qualification, Cleaning Validations, FDA Audit Preparation and more. 
In 2013 I started my 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.