Broadcast Date: Tuesday, February 22, 2022
from 12:00 pm to 1:30 pm (ET)

Overview:

Conducting an internal investigation is a critical step to consider when allegations of misconduct come to light. However, the increased organizational risks brought by the COVID-19 pandemic, including the significant uptick in complex internal complaints, have turned this aspect of business operation even more challenging.

Companies today must start prioritizing effective internal investigations strategies to avoid potential risks and issues. They need to adapt their approaches in the post-COVID-19 era while maximizing protection and compliance. Thus, practical preparedness related to the essential steps and guiding principles of internal investigation is necessary to weather all challenges that might come in the process.

Listen as a panel of key thought leaders and practitioners organized by The Knowledge Group provide the audience with the best practices and key considerations to maintain compliance when conducting internal investigations in a post-COVID-19 era.

In a LIVE Webcast, the speakers will discuss:

  • Overview of the Internal Investigation Process
  • COVID-19 Implications
  • Challenges and Pitfalls
  • Best Practices for Investigations
  • Essential Steps to Prevent Potential Risks

Credit:

Course Level:

Intermediate

 

Advance Preparation:

Print and review course materials

 

Method of Presentation:

On-demand Webcast (CLE)

 

Prerequisite:

General knowledge of internal investigations

 

Course Code:

149917

 

NASBA Field of Study:

Business Law – Technical

 

NY Category of CLE Credit:

Skills

 

Total Credits:

1.5 CLE

Speaker Panel:

Michael D. Farber, Partner
Van Ness Feldman LLP

Mike Farber has twenty years of experience, both as a partner in private practice and as a government official, in rapidly assessing, investigating, and resolving compliance issues across a wide variety of industries. Drawing upon his experience both in private practice and at the U.S. Department of Justice, Mike represents clients in federal and state antitrust investigations, complex litigation, and intricate compliance matters. Mike also provides strategic advice and counsel on national security matters related to incident response and the protection of environmental and energy infrastructure from cyber and physical threats.

Prior to joining Van Ness Feldman, Mike served as the Senior Advisor to the Director of the Bureau of Safety and Environmental Enforcement (BSEE) at the U.S. Department of the Interior, where he spent six years leading a number of initiatives reforming U.S. government oversight of offshore oil and gas operations. During his tenure at BSEE, spanning the initial five years of the agency’s existence, Mike led or was involved in all significant BSEE enforcement and investigative matters.

Mike serves as a member of Van Ness Feldman’s Executive Committee, co-coordinator of the firm’s Diversity and Inclusion Committee, and formerly served as co-coordinator of the firm’s Litigation and Investigations Practice.

Elizabeth J. McEvoy, Partner
Hinckley Allen

Elizabeth is an experienced litigator and advisor who focuses her practice on healthcare litigation and government investigations/white-collar criminal defense. She is the Chair of the firm’s Research Misconduct & Integrity Practice Group, where she draws on her healthcare and white-collar defense background in representing individuals and institutions in a variety of research integrity and compliance matters, including research fraud/misconduct, sexual harassment/hostile work environment, conflicts of interest, foreign influence on US-based research, and violations of the False Claims Act. She is among the most experienced litigators who has advised and defended allegations of scientific research misconduct (falsification/fabrication of data), and brings a multi-disciplinary perspective to advise federal grant recipients on alleged misuse of federal funds and related non-compliance with NIH, NSF, ORI, and DOJ terms and conditions.

Beth P. 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.

Agenda:

Michael D. Farber, Partner

Van Ness Feldman LLP

  • There are many uncertainties in how organizations will operate in the post-COVID era, but one thing that is nearly certain is that there will be a constant need to conduct internal investigations to assess evidence or complaints of wrongdoing within companies.
  • The central challenges of internal investigations remain the same – thoroughly assessing compliance risk, determining root causes of non-compliance, and identifying potential compliance reforms to prevent recurrence.
  • The two years of COVID restrictions have forced internal investigation teams to operate remotely, including employee interviews and evidence gathering.  Companies will expect that best practices and efficiencies will be implemented in future internal investigations.
  • Flexibility on the use of videoconference interviews should open up new strategies, including the potential staggering of interviews.  This may also allow for more document and data analysis between interviews.
  • There is likely to be an increased reliance on forensic document and data analysis.
  • Federal and state agencies will, under the leadership of the U.S. Department of Justice, will expect internal investigation briefings to thoroughly address both individual employee conduct and company compliance history.

Elizabeth J. McEvoy, Partner

Hinckley Allen

  • Conduct of investigation: Pros/cons of in-person vs. Zoom interviews. The pandemic has opened up new opportunities for connecting with witnesses and government regulators, but each have their challenges. Interviewer will want to consider the need for a thorough credibility determination, and whether personal presence is essential, as well as scheduling concerns, comfort of witnesses, ability for influence or outside coaching or notes in a virtual setting, etc.
  • New challenges to preserving privilege in an internal investigation: The decline in face to face conversations creates a much more voluminous record between investigators and their clients, witnesses and investigators, internal decision makers, and even among investigators. Each category may be subject to discovery by government subpoena or in civil litigation if not carefully preserved and safeguarded as privileged. Interim status reports should be designed to address these risks, including the benefits of live discussion over email and traditional phone calls. Additional planning should go into how, and to what audience, any verbal presentation of findings will take place. It may be more difficult to get a captive audience and convey difficult or nuanced results. On the other hand, investigators can take advantage of recorded interviews and interactive PPTs to better present findings if confined to Zoom.
  • Lack of an epicenter for company-based investigations: Most clients are adjusting to remote or hybrid schedules, cognizant of not overcrowding traditional office space. The lack of a fully staffed corporate office often presents a challenge to investigators accustomed to “being on site” and not just speaking to employees and witnesses, but also observing the physical space and atmosphere of an organization. It is critical to try and schedule a site visit where the concern pertain to cultural expectations or specific acts of wrongdoing at an institution, even if during off hours or on a weekend. Additionally, investigators need to be more organized in how to collect, exchange, and organize files obtained from an organization, which investigators not always based at the office or able to simply review files maintained on site. Firms should set up internal libraries that provide broad access to clients and investigators and explore using shared documents to stay organized.
  • Impact on culture investigation: Many areas of the law now focus on workplace climate and potential hostile environments. COVID/based staffing, safeguards, and remote working arrangements have created a new challenge to assessing an institutional culture or patterns of harassment. The lack of daily interaction can dull or make it harder to identify offensive conduct. However, the increased reliance on intraoffice platforms such as Slack, Microsoft Teams, and email/text often creates a more robust record for finding documentary evidence and confirming/contradicting anecdotal evidence.

Beth P. WeinmanCounsel

Ropes & Gray

  1. Best Practices for Conducting Internal Investigations-during the COVID Era and Beyond
    1. Use well trained, experienced investigators. Consider who has responsibility for the investigation and implications for privilege. Consider whether specialized regulatory or subject matter expertise is necessary for the investigation team.
    2. Develop an investigation checklist to refer to during investigation so critical steps are not overlooked.
    3. Consider key strategy issues and don’t hesitate to revisit prior calls (i.e. order of investigation, whether witnesses need separate counsel, how findings should be memorialized)
    4. Frame investigation strategy and reporting of findings around 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 but which is also relevant in non-criminal cases.
    5. Make sure compliance infrastructure is a subject of the investigation as well. Interrogate what worked and what didn’t work and why.
    6. Identify root causes of improper conduct and develop remediation actions tied directly to those root causes. Consider termination when appropriate but termination alone is usually insufficient. Improved policies, training and auditing should go along with individual HR recommendations.
    7. Consider whether self-reporting may be appropriate and to whom.
  1. Internal investigations are critical for identifying problematic conduct and the root causes for such conduct so that action can be taken quickly to prevent problems from compounding, and so companies can be prepared if and when the government decides to investigate. But workplaces that have become partially or even largely remote due to the pandemic can present unique challenges for investigations that may require special consideration to overcome.
    1. A sense of community, collegiality and cohesiveness can disintegrate when people don’t spend time together, allowing perceived slights to fester and potentially leading to an increase in complaints and less willingness to give colleagues the benefit of the doubt. Also, COVID-related requirements and pressure to return to the work place can cause anxiety for some. Investing time and resources into community building (formal or informal) may ease anxiety, increase morale and reduce complaints.
    2. With fewer opportunities for in person contact, some companies may have a significant increase in written communication. Statements can be taken out of context and the amount of evidence relevant to any investigation may sky rocket. Make sure to have virtual meetings or phone conversations periodically some issues can be discussed live. Make sure to train employees on appropriate communication.
    3. Interviews can be difficult in person if interviewer and interviewee are masked. The ability to read a person’s face can be compromised and sometimes it can be hard to hear what people are saying—especially if meetings are hybrid remote and in person. Conducting interviews remotely can solve the mask problem but create other limitations. A witness alone in his or own home may be more nervous or less forthcoming than in a conference room surrounded by colleagues. In house counsel should appropriately prepare witnesses for the context and logistics of an investigation interview ahead of time to make sure there are no misunderstandings and to alleviate anxiety. This will make fact finding much easier.
  1. The Deputy AG Lisa Monaco announced recently that DOJ considering a company’s entire enforcement history (criminal, civil, regulatory) when considering the appropriate resolution to a government investigation or enforcement action. This makes uncovering potential compliance breaches, investigating them and remediating them early, before discovery by regulators, more critical than ever.
    1. Companies should make sure avenues to tee up complaints are well publicized, employees feel comfortable speaking up, and that there is a robust process in place for complaint evaluation.
    2. A comprehensive audit program should run in parallel to complaint investigation.

Date & Time:

Tuesday, February 22, 2022

12:00 pm to 1:30 pm (ET)

Who Should Attend:

  • Internal Investigations Officers
  • HR Professionals
  • Audit Committee Members
  • Regulatory Compliance Managers
  • Risk and Compliance Officers
  • Legal Compliance Analysts
  • Legal and Compliance Executives
  • General Counsel
  • Top-Level Executives
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SPEAKERS

Michael D. FarberPartner
Van Ness Feldman LLP
Elizabeth J. McEvoyPartner
Hinckley Allen
Beth P. WeinmanCounsel
Ropes & Gray

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