At QualityHub, we have experience in consent decrees for several types of companies and situations. Here are two examples of consent decree case studies to give you some background on that experience.

Third-Party Experts

Consent Decree Case Study – 18 Months

• Performed verification audits of the client’s quality systems
• Performed in-depth reviews of client’s DHFs, CAPAs, risk documentation and all related documents based on consent decree requirements (due to “product issues”)
• Worked with company management and in-house attorneys on strategy
• Attended meeting with FDA District Office
• Worked with the client’s external FDA attorneys

Interim Professionals, Team Leads, Trainers, Coaches and SMEs

Consent Decree Case Study – 2 Years

• Performed audits prior to the consent decree
• Met with FDA local district management, CDRH, ORA and attorneys
• Provided Acting/Interim Quality Manager, Complaints Manager, CAPA Manager, Sustaining Engineering Manager
• Provided Remediation Team Leads and SMEs: Corrections & Removals, Computer System Validation, Management Controls, Internal Audit, Risk Management and Design Controls, CAPA and other areas as needed
• Provided FDA compliance training to senior management
• Worked with company management and in-house attorneys on strategy
• Worked with the client’s external FDA attorneys
• Managed the back-room during Certification Audits and FDA Inspections

*Note: Certification performed by another consulting company.