FDLI’s Enforcement, Litigation, and Compliance Conference: For the Drug, Device, Food, and Tobacco Industries

Partner Dennis Gucciardo will speak on "Quality Risk Management (QRM) During a Pandemic and After: Essential Components of Risk Management During a Public Health Crisis" on December 16th during FDLI’s 2020 Enforcement, Litigation, and Compliance Conference.

During the pandemic, many global regulators identified opportunities for acceleration to speed vital products to market. In the US, this is being done using Emergency Use Authorizations for certain products. In order to meet market need during the crisis, there are certain Quality Risk Management issues that need to be considered by all members of the supply chain in order to assure that products that are produced for patients are of the highest quality.

This panel will discuss what risk assessments need to be completed, from facility level through technical and operational risk assessment and others, in order to manufacture products at a high volume to meet market need without compromising quality. Speakers will also discuss various scenarios once the EUA is lifted and production moves into a steady state.