Consent Decree Mitigation

The Partnership

Was a large Midwestern solid/liquid oral dosage form manufacturer that had just signed a consent decree,

The Need

  • Resolve significant compliance observations, coordinate with oversight body and coach staff.

  • All operations had ceased and products recalled. Aggressive timelines to meet FDA expectations.

  • Served stakeholders by auditing systems, placing key skilled personnel in place to resolve issues.

  • Culture shift needed at all levels. Unique skills necessary to coordinate all activities with all stakeholders.

The Process

Complete quality, operation, utility, facility and equipment systems overhaul.

Developed Work Plan

On site with team to assess the systems, develop work plan and coordinate with oversight body/FDA.

Lead Execution Strategy

Complete quality, operation, utility, facility and equipment systems overhaul.

Exceed Partner Expectations

Did not overwhelm partner with auditors/consultants. Timely execution, served various hands-on roles.

Re-started Operations

Provided oversight for first product to be approved for manufacture and shipment since the Consent Decree.

Coach and Mentor

Coached existing and new partner colleagues. Mentored by serving as interim Quality Director and OPS Excellence QA.

Successful Results

Compliant programs established to fit our partners systems. Provided options and viable pathways for compliance. Production and shipments resumed.

Gain Our Insight

LET'S GET STARTED
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