Case Study: Consent Decree Projects

  • QualityHub
  • January 17, 2020
  • 2-Minute Read

Consent Decree Case Studies

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.

1. 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

2. 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.

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About the Author

QualityHub is a top FDA compliance consultant company headquartered in Orlando, FL. Serving internationally, QualityHub delivers customized quality system solutions for navigating medical device and pharmaceutical FDA regulations.