Risk Based Manufacturing Compliance: Consent Decree Experience

1
Risk Based Manufacturing Compliance Consent
Decree Experience

• Bruce Burlington, MD
• Executive VP, Quality, Safety, Regulatory,
  Compliance

2
Understand the Consent Decree Messages

• Take management responsibility
• Improve quality unit review
• Implement current policies procedures
• Follow your procedures
• Validate equipment, processes, and methods
• Improve failure investigations CAPA
• Share what is learned across network
• Meet regulatory commitments

3
Responding to a Consent Decree

• Fulfill commitments and achieve compliance
• Leadership
• Project manage remediation
• Simplify eliminate products and sites
• Rebuild facilities, IT systems, quality systems,
  management controls
• Change culture management, work relationships,
  attitudes
• Business response to enforcement
• Prepare for the long term
• Cost of compliance and non compliance
• Commit to highest level of quality and compliance

4
CD Investments
CD Effort, Commitments, Sustainability
FTE
CD Remediation
For Two Sites
1.2 million
Projected
Person-Hours
Years 3-5
Person-Hours First 2 Years
1.8 million
5
Costs of a Consent Decree

• Disgorgement and fines
• Legal fees
• Loss of revenue
• Products suspended and discontinued
• New products delayed
• Third party experts
• Additional quality and manufacturing staff
• New IT systems and facilities
• Management attention
• Reputation with customers and Wall Street
• Opportunity forgone