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.
