FDA’s recall authority and program launches you into a project of crisis management. You will learn how to establish a roadmap for conducting recalls. The recall management knowledge you gain will sharpen how you determine the health and legal risks associated with your recall and what you can do to avoid future recalls. You will understand the critical performance targets to accomplish an effective recall and learn how missteps in the recall process become counterproductive and expensive. You will take away practical knowledge on how to work with FDA staff during a recall and how you can prepare for inspectional follow up or an enforcement action. You will learn that your approach to an enforcement action plays a major role in mitigating the firm’s business consequences due to a recall. A firm with a history of chronic recalls needs to learn how to get out of that downward spiral. Likewise, for established and new firms you will learn how you can reduce the likelihood or significance of a recall with proper planning.
Learn practical tips from your course instructor Mr. Casper (Cap) Uldriks who brings over 32 years of experience from the FDA. He specialized in the FDA’s medical device program as a field investigator, senior manager in the Office of Compliance and as an Associate Center Director in the Center for Devices and Radiological Health. Many of his engagements focus on advertising and promotion, recalls, corrections and removals and enforcement. His comments are candid and of practical value. He understands how the FDA thinks, operates and where it is headed. He developed enforcement actions, participated in the implementation of new statutory requirements, managed device regulatory programs and was recognized as the agency’s expert in a number of statutory provisions and regulations.
- Understand FDA’s recall authority and policy
- Learn the mandatory requirements for device recalls
- Learn how to interact with FDA
- See how to develop health risk determinations
- Learn critical recall strategy components
- Identify options for FDA enforcement action