Corporate Compliance & Liability: What Medical Product Professionals Need to Know - Webinar Recording/Transcript

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Corporate Compliance & Liability: What Medical Product Professionals Need to Know

It’s easy to lose sight of the big picture. But you do so at your peril.

Take violations. You probably worry about warning letters and Forms 483, never giving a thought to criminal charges. But they happen too, more often than you think.

FDAnews has called on a top litigator with extensive criminal-law expertise, and a prosecutor too, for a rare learning session that steps back to focus on the big picture … then zooms in on details that can keep you out of trouble.

Your presenters are Mark C. Levy Esq., and Asst. U.S. Atty. Elizabeth Abrams Esq. They’ll show you both sides of the law — defense and prosecution — in a must-attend presentation that could pay off for many many years. Among things you’ll discover:

The Big Picture:

  • Justice Dept. policy on compliance programs, a process that has direct impact on regulatory and quality professionals
  • The FDCA and the False Claims Act: Enforcement and the impact of whistleblowers
  • Criminal and civil liability: Strategies to avoid both

The Fine Points:

  • Process validation [21 CFR 820.75(a)]: Building a system that works
  • Purchasing controls [21 CFR 820.50]: Keeping your supply chain clean
  • Conforming products [21 CFR 820.90(a): Conforming to specified requirements

We all get stuck in a hole sometimes. In the day-to-day focus on the FDA, it’s easy to lose sight of how other agencies may be helping — or hurting — you. Are you aware of the latest Justice Dept. guidance on what makes an effective compliance program? This is a rare opportunity to discover … to climb out of that hole for a look around.

Who Will Benefit

Drugs, devices, diagnostics: Every FDA-regulated health sciences organization can benefit:

  • C-Suite
  • Legal affairs
  • Regulatory/compliance
  • Quality control
  • Marketing/sales
  • Strategic planning

Meet Your Presenters

Mark C. Levy Esq. is a partner with Eckert Seamans Cherin & Mellott, representing clients in heavily regulated industries including drugs and devices, defense and transportation. His cases include both civil and criminal charges, and expertise ranges across the Food Drug & Cosmetic Act, False Claims Act, Medicare/Medicaid regulations and Federal Acquisition regulations.

Fellow panelist Elizabeth Abrams Esq. is Assistant U.S. Attorney for the Eastern District of Pennsylvania, in the Criminal Division. Prior to working as a federal prosecutor, she spent eight years in private practice at Reed Smith LLP.