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.