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One Day Online Training Workshop (November 9, 2020)
How to Keep Your Operations Working in a Pandemic: Crisis Management for the FDA-Regulated Industry Although the coronavirus pandemic of 2020 presents a unique worldwide crisis unlike anyone has experienced in their lifetime, the systems needed to deal with the pandemic and other crisis should be built into practices and operations of all FDA-regulated industry. Medical and health care product companies routinely encounter crisis events that require careful regulatory strategic planning, diligent execution and persistent follow-up to ensure successful address of the crisis. Unlike risk management, which involves managing potential and known threats of narrow scope, crisis management involves managing unknown threats during and after their occurrence. A crisis event, if not managed adequately and timely, could negatively affect the status of applications with the FDA, public image, and financial status of the company. Crisis events also usually offers opportunities otherwise not available that can be used to the company’s benefit during, and after the crisis is long over. This one-of-a-kind workshop will teach first-hand what is involved in developing and implementing a crisis management plan for FDA-regulated companies. The role of FDA guidance and interactions; employee, external stakeholder and media communications; quick response time; and reputation management will be discussed using real-life examples from the COVID-19 Pandemic 2020. The presenters will discuss the industry perspective for handling crises for the FDA-regulated industry. Who Will Benefit:
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For additional information on the workshop agenda and logistics, please call 410-501-5777 or email: info@fdamap.com
