Life Sciences Enforcement Operations LAB: Building the First 72-Hour Response to FDA, DEA, DOJ and State Scrutiny

Feb 3, 2027 10:00 am – 4:00 pm

The Life Sciences Enforcement Operations LAB is a limited-seat, scenario-driven intensive focused on the critical first 72 hours following FDA, DEA, DOJ or state scrutiny.

Through an escalating enforcement scenario, attendees will make real-time decisions around regulator interactions, investigations, privilege, internal escalation and business continuity while building a practical response playbook they can adapt for their own organization.

Designed for legal, compliance, quality, regulatory, investigations and operations leaders across the broader life sciences market, the LAB emphasizes execution and decision-making rather than traditional regulatory updates or panel discussion.

LAB Outline

10:00 am
Welcome, Scenario Briefing & Response Team Assignments
10:15 am
The Knock at the Door: Classifying the Government Contact & Taking Immediate Action
10:55 am
Activating the Response Command Structure: Who Leads, Who Decides & Who Communicates?
11:50 am
Managing Regulator Access, Employee Interviews, Documents & Data
12:30 pm
Working Lunch: Benchmarking Your Response Readiness
1:30 pm
The Matter Expands: Coordinating FDA, DEA, DOJ & State Authorities
2:10 pm
Protecting Operations, Patients & the Business While the Investigation Continues
3:05 pm
Reporting Up & Remediating Without Making the Situation Worse
3:35 pm
Stress-Testing & Completing Your First 72-Hour Enforcement Response Manual
4:00 pm
LAB Debrief & Closing Remarks

View Agenda

Build your Complete First 72-Hour Enforcement Response Manual

Leave with a practical, customizable framework that can be adapted for FDA inspections, DEA inquiries, DOJ investigations, subpoenas, records requests, and multi-agency enforcement actions. Participants will leave with a practical enforcement response toolkit, including:

  • Response Team Role Map
  • Government Contact Decision Tree & First-Response Checklist
  • Response Command Structure & Responsibility Matrix
  • Regulator Access, Interview & Evidence Preservation Protocols
  • Response Readiness Gap Assessment
  • Multi-Agency Coordination Map & Communications Log
  • Business Continuity & Operation Risk Decision Framework
  • Executive Reporting Template & Remediation Decision Matrix

Who Should Attend

This LAB is designed for the broader life sciences and healthcare market, not only controlled substances professionals. Through an immersive, scenario-based exercise, participants will focus on execution, decision-making, and organizational readiness rather than regulatory updates or traditional panel discussions. This workshop is designed for leaders responsible for:

  • General Counsel, Legal & Litigation
  • Compliance & Ethics
  • Regulatory Affairs
  • Government, Internal & Corporate Investigations
  • Controlled Substances Compliance
  • Pharmacy Compliance & Operations
  • Quality, Quality Systems & Risk Management
  • Security, Global Security & Asset Protection
  • Supply Chain, Distribution & Logistics
  • Operations & Manufacturing
  • Enterprise Risk Management
  • Crisis Management & Corporate Communications
  • Business Continuity & Resilience
  • Audit & Monitoring Functions
  • Executive Leadership Responsible for Enforcement Response