Don’t let your company be at the mercy of your global supply chain — there are steps you can take to address the challenges. Learn how others have managed the supply chain during the pandemic. Come away with solid strategies for ensuring such challenges don’t result in drug shortages.

Ever wanted to be a fly on the wall of the FDA’s Center for Drug Evaluation and Research (CDER) Office of Compliance? This is your exclusive opportunity to hear about the latest in trends, the impact of COVID-19 on the FDA operations and new guidances to be aware of concerning manufacturing quality.

The medical device single audit program (MDSAP) is supposed to streamline processes and minimize disruptions, enabling you to get your devices to market faster. If virtual MDSAP inspections are throwing you a curve ball, this session is essential. You’ll get a handle on how remote MDSAP assessments are being conducted, best practices for managing remote inspections and the biggest virtual MDSAP challenges companies face — and how to mitigate them.

The hard truth is that there’s been an increase in medical device recalls in 2020. How can you avoid or lessen one? This session looks at the primary drivers of this increase. Is the COVID-19 pandemic a contributing factor? Do you know what to inspect in a recall inspection? And to report or not to report — and if reporting, when? The answers to these questions and more will be revealed, so you can be prepared.

The pandemic is affecting every segment of the clinical trials industry, sometime in the same way and sometimes a little differently. Find out the real impact on sponsors, CROs, sites, and IRBs, in terms of what’s now being called virtualization. And take a deep dive into the muddy waters of a post-COVID era to start to figure out its lasting effects.

Are you feeling overwhelmed by the weight of scrupulously monitoring your vendors? Do you know how to avoid regulatory red flags and ensure compliance? The key to success is to vet early and often to avoid wasting time and money. But what are the best practices? In this session, you’ll find out how to maximizing opportunities for cooperating in a regulatory environment.