PLAY RECORDING

Broadcast Date: Thursday, October 07, 2021
from 12:00 pm to 1:00 pm (ET)

Overview:

When the government comes knocking with a subpoena in hand, companies need to launch an internal investigation to uncover potential wrongdoing and determine how to respond to the government. The U.S. Department of Justice (DOJ) has made it very clear that it will focus intently on the robustness of a firm’s commitment to compliance with applicable laws when determining how to address potential wrongdoing. A firm’s compliance infrastructure and its financial and cultural commitment to that infrastructure will figure prominently in how the government evaluates a company’s conduct. However, unique challenges and complexities have started to emerge in connection with the ability to monitor and increasingly remote work force, and organizations will have to be proactive in ensuring their compliance programs keep up with these changes.

In this LIVE CLE Webcast, FDA compliance and enforcement attorney Beth Weinman (Ropes & Gray) and DOJ Consumer Protection Branch Prosecutor John Claud (U.S. Department of Justice), will discuss best practices for investigating potential misconduct and engaging with and responding to DOJ when it has launched an investigation into such misconduct, with a significant focus on the role that effective compliance programs play. While focused on DOJ investigations, the best practices addressed are broadly applicable to all government investigations.

Some of the major topics that will be covered in this course are:

  • Government Investigation Trends and Developments
    • Government Investigations Under the Biden Administration
    • Implications of the COVID-19 Pandemic in Conducting Government Investigations
  • Identifying Red Flags
  • Common Risks and Pitfalls
  • Key Considerations When Your Company is Subject to an Investigation
  • Best Compliance Practices

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-demand Webcast (CLE)

 

Prerequisite:

General knowledge of Government Investigation

 

Course Code:

149500

 

NY Category of CLE Credit:

Area of Professional Practice

 

Total Credit:

1.0 CLE

Speaker Panel:

Beth Weinman, Counsel
Ropes & Gray

Beth Weinman, Counsel in Ropes & Gray’s FDA regulatory practice group, focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices including diagnostics, and dietary supplements. Beth represents clients in investigations concerning alleged violations of the Federal Food, Drug, and Cosmetic Act (FDCA) and False Claims Act (FCA). She also provides regulatory and compliance counseling related to marketing practices, good manufacturing practices, good clinical practices, compounding, and product recalls and withdrawals. Beth joined Ropes in 2018 from FDA’s Office of Chief Counsel, where she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies on FDCA and FCA investigations and enforcement.

John Claud, Assistant Director, Consumer Protection Branch
U.S. Department of Justice

John Claud is an Assistant Director at the Consumer Protection Branch of the U.S. Department of Justice. He has litigated numerous civil and criminal matters relating to violations of the Food, Drug, and Cosmetic Act and other statutes, and is the coordinator of CPB’s national oversight of FDCA criminal cases. Before joining DOJ, John was an associate at Cadwalader, Wickersham & Taft. He started his career as an Assistant District Attorney in the Manhattan D.A.’s Office. John is a graduate of Trinity College (Ct.), holds a master’s degree from the University of Colorado, and is a cum laude graduate of the Catholic University of America Columbus School of Law.

Agenda:

Beth Weinman, Counsel

Ropes & Gray

AND

John Claud, Assistant Director, Consumer Protection Branch 

U.S. Department of Justice

  1. Counsel for organizations would benefit from being familiar with DOJ’s Principles of Federal Prosecution of Business Organizations, the formal Department guidance that Federal prosecutors follow to assess how to resolve such criminal actions.
  2. Understanding these Principles can be a key part of designing and implementing a successful and legitimate corporate compliance program.
  3. Understanding these Principles can also be key part of determining how a target organization responds to government inquiries.
  4. The DOJ continues to believe the cornerstone of combatting corporate misconduct is to determine the role of and hold accountable all individuals who engage in wrongdoing.
  5. Conversely, Federal prosecutors also work to find common ground with responsible corporate leaders.

Materials:

Download Course Materials

Who Should Attend:

  • White Collar Defense Attorneys
  • False Claims Act Lawyers
  • Corporate Counsel
  • General Counsel
  • Risk and Compliance Officers
  • Top-Level Executives

SPEAKERS

Beth WeinmanCounsel
Ropes & Gray
John ClaudAssistant Director, Consumer Protection Branch
U.S. Department of Justice

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