Experience and Capabilities
Summary of Service Offerings
Quality Systems:
Establish strategic direction and streamline quality systems to be compliant, effective, and efficient
Quality and Operation Culture:
Evaluate current culture and support cultural change
Manufacturing and Product Investigations:
Coordinate investigations of significant events to identify impact, root cause, and corrective and preventive actions
Personnel Training:
Develop and provide customized training for manufacturing, technical support and quality assurance organizations
Inspection Preparation and Response:
Support inspection readiness, response, and remediation
Risk Assessments:
Coordinate risk assessments to allow for understanding of current state of compliance and how to most effectively utilize resources
Validation:
Support for process, equipment, facility, and analytical validation