Conducting Internal GMP/QSR/GCP/GLP Investigations

precon

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:30 a.m.

Whistleblower Allegations in a GMP/QSR/GCP/GLP Environment

  • Hotline calls and other complaints
  • Purpose of internal investigations

9:30 a.m. – 10:15 a.m.

Overview of Whistleblower Protections/Increased Government Oversight of Corporate Conduct

10:15 a.m. – 10:30 a.m.

BREAK

10:30 a.m. – 12:00 p.m.

Do We Investigate?

  • When is an internal investigation required? When is it discretionary?
    • Investigations mandated by regulation, statute, or corporate policies
    • Whistleblower complaints and whistleblower credibility
    • Risk assessments when investigation is not mandatory
  • Who should run the investigation?
    • Internal versus outside counsel
    • Determining the role of senior executives, audit committees, board of directors, etc.
    • Considering conflicts of interest when staffing investigations
    • Clarifying the terms of engagement and appropriate role of outside counsel

Exercise — Evaluation of Hotline Complaint and Recommendations for Next Steps

12:00 p.m. – 1:00 p.m.

LUNCH

1:00 p.m. – 2:30 p.m.

What Is Our Plan?

  • Identifying issues and objectives
  • Determining appropriate scope
  • Budgeting for an internal investigation
  • Considering how corporate policies and procedures should impact the investigation (e.g. corporate privacy policies, etc.)
  • Engaging third-party vendors and forensic specialists
  • Special considerations for multinational investigations
  • Strategic plan for managing internal messaging regarding the investigation
  • Strategic plan for managing external messaging, including public disclosures and responses to media inquiries
  • Protecting the privilege through an internal investigation

Exercise — Developing the Investigation Plan

2:30 p.m. – 2:45 p.m.

BREAK

2:45 p.m. – 4:30 p.m.

Conducting the Internal Investigation

  • Document collection and review
    • Litigation hold notices
    • Custodian interviews and identifying potential sources of documents
    • Defining the scope of document collection
    • Methods of document collection
    • Document review process and considerations
  • Conducting witness interviews
    • Deciding who to interview
    • Planning and preparing for the interview
    • The Upjohn warning
    • Tips and tricks for conducting the interview
    • The challenging interview: dealing with reluctant, hostile, and lying witnesses
    • Memorializing the interview and determining next steps
  • Documenting the investigation, providing internal updates, and taking interim action
    • Documenting the investigation and keeping key evidence organized
    • Written versus oral updates
    • Keeping senior management, the audit committee, or the board informed
    • Deciding whether and to what extent to take immediate corrective action, including disciplining or terminating employees
  • Deciding when to conclude the investigation

Exercise — Best Practices For Witness Interviews

 

4:30 p.m.

ADJOURN DAY 1

 

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