Core Insights - The "FDA Recalls Masterclass" training aims to enhance recall management strategies and compliance with FDA regulations [1] - The course emphasizes the importance of identifying root causes of recalls and implementing corrective and preventive action programs to avoid future issues [2] - Effective recall management is crucial for maintaining a company's reputation and minimizing financial losses associated with recalls [3] Training Overview - The training will cover essential aspects of FDA recalls, including definitions, types (Class I, II, III), and the FDA's recall authority and policy [8] - Participants will learn how to manage recalls under FDA oversight, interact with FDA staff, and develop health risk determinations [9] - The agenda includes sessions on proactive recall readiness, risk-based planning, executing recalls, and post-recall actions [10] Target Audience - The training is designed for recall managers, quality assurance managers, regulatory affairs directors, risk and product liability managers, and manufacturers [9] - It is also relevant for healthcare institutions, nursing homes, and medical practice groups [9] Key Topics - The course will address building compliant recall plans, setting up cross-functional recall teams, and conducting mock recall exercises [11] - It will cover notification procedures, managing media communications, and ensuring compliance through effectiveness checks [11] - Participants will engage in discussions on common pitfalls and best practices in recall management [11]