Conducting Internal GMP/QSR/GCP/GLP Investigations

precon

8:30 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 10:15 a.m.

Individual Liability and the Park Doctrine

  • The evolution of potential individual exposure during the course of an investigation
  • What is the Park Doctrine?

Exercise — Case Studies Involving Application of the Park Doctrine


10:15 a.m. – 10:30 a.m.

BREAK

10:30 a.m. – 12:00 p.m.

We Know What Happened, Now What?

  • Considering whether to create a final report and determining what to include
  • Deciding whether and when to voluntarily disclose misconduct
  • Taking disciplinary action
  • Delivering results to senior management, the audit committee, or the board
  • Anticipating backlash: preparing for increased government scrutiny, shareholder lawsuits, and media inquiries
  • Preventing whistleblower retaliation

Exercise — Reports to Senior Management and Audit Committees

12:00 p.m. – 1:00 p.m.

LUNCH

1:00 p.m. – 2:30 p.m.

Building a Culture of Compliance: It Starts at the Top

  • Top down commitment to quality and compliance
  • Risk assessment
  • Developing and revisiting policies and procedures
  • Employee training
  • Document tracking
  • Anonymous reporting
  • Considerations in developing reporting chains

Exercise — Developing a Corrective Action Plan

2:30 p.m. – 2:45 p.m.

BREAK

2:45 p.m. – 4:00 p.m.

Exercise — Liability for GMP/QSR/GCP/GLP Violations (Case Studies)

4:00 p.m. – 4:30 p.m.

Wrap Up – Best Practices

4:30 p.m.

ADJOURN DAY 2

 

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