FDAnews Announces — Corporate Compliance & Liability: What Medical Product Professionals Need to Know Webinar, Aug. 22, 2018
FALLS CHURCH, Va. (PRWEB) August 09, 2018 -- Corporate Compliance & Liability:
What Medical Product Professionals Need to Know
**An FDAnews Webinar**
Aug. 22, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/corporatecomplianceliability
Whatever the business, drugs, devices, or diagnostics, compliance rules it.
But what is compliance? How does the Justice Dept. view it? Where lies the borderline between civil violation and criminal liability? How about false claims, whistleblowers? And what are the hidden costs and potential benefits of a well-managed compliance program?
Mark the calendar for a webinar where attendees will step back to see the big picture and zoom in on details that can keep them out of trouble.
The presenters are Mark C. Levy Esq., a litigator with deep criminal-law expertise, and Asst. U.S. Atty. Elizabeth Abrams Esq. They’ll show both sides of the law, defense and prosecution, in a must-participate presentation that could pay off for many many years. Attendees will 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 the supply chain clean
- Conforming products [21 CFR 820.90(a): Conforming to specified requirements
In the day-to-day focus on the FDA, it’s easy to lose sight of how other agencies may be helping or hurting.
Meet the 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.
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
Webinar Details:
Corporate Compliance & Liability:
What Medical Product Professionals Need to Know
**An FDAnews Webinar**
Aug. 22, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/corporatecomplianceliability
Tuition:
$287 per site
Easy Ways to Register:
Online: http://www.fdanews.com/corporatecomplianceliability
By phone: 888-838-5578 or 703-538-7600
About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.
Michelle Butler, FDAnews, http://www.fdanews.com, +1 703-538-7600, [email protected]
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