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What are the GMP requirements for complaint documentation and management? What are the GMP standards for an effective recall system? How to identify the key issues in product complaint and recall handling? How the FDA responds to adverse event reports and the regulatory consequences for not 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.
Key Learning 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
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Joy McElroy
With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.
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