Sr. Project Management Consultant Integrated Project Management Company, Inc.
Medical device and pharmaceutical organizations are often faced with crisis situations requiring regulatory affairs’ leadership. Warning letters, consent decrees, product quality issues, regulatory inspections, supply chain disruptions, and other crises require immediate regulatory attention. When an unplanned event disrupts your organizational ecosystem or threatens your products, the very existence of your business may be at risk. How your organization responds will make the difference between a negative or positive outcome and determine the magnitude of the impact.
During this discussion with experts from the medical device and pharma/biotech industries, we will talk through a step-by-step approach to best handle crises that may distract your organization from its day-to-day business. The conversation will provide real-world experiences, advice, and strategies to help guide you on the path to minimizing the impact of crises that are inevitable in these industries.
Describe the importance of pre-planning to avoid crises or mitigate the impact.
Apply key factors in developing a crisis management plan.
Utilize critical techniques to successfully execute the plan and decrease the likelihood of future crises.