The Partnership
Was established by a medical device firm to resolve significant GMP observations and change company culture
The Need
Completely resolve FDA issues and restart operations.
An appropriate number of hands-on, skilled colleagues that would lead change and perform.
Ability to meet aggressive timelines.
Culture change catalysts for all levels of employees.
The Process
Collaborated on the response, timeline and compliance actions to mitigate the situation.
Dedicated, Skilled Team
Customer centered support with focus on re-establishing the credibility of our partner with the FDA.
Apply FDA Expertise
Collaborated on the response, timeline and compliance actions to mitigate the situation.
Enhance Existing Systems
Improvements developed by a collaborative effort with our partner on existing Quality Systems.
Company Cultural Shift
Top down / bottom up adult learning program to understand and remediate the causes of non-compliant activities.
Complete Transformation
Communicated with FDA and provided periodic reports. Complete, effective systemic evolution.
Successful Results
Warning Letter resolution and no further FDA actions. Company quality culture shift that empowered all employees. Common-sense, practical system enhancements that eliminated waste and improved performance.