Crisis Resolution

Crisis Resolution

  •     CAPA system design, management and closure
  •     Regulatory deficiency FDA 483 and warning letter response
  •     Field complaint and product reliability issues
  •     Interim functional leadership

Case Studies

Led core team for FDA warning letter response at medical device manufacturer.  Improved quality system procedures, validated out-of-compliance processes, and laid groundwork to re-validate common processes across multiple product lines.

Results: Passed FDA follow-up audit with no observations.

Served as interim director of engineering and operations for small medical device manufacturer/distributor after incumbent’s unplanned departure. Led and coached staff while improving processes. Developed optimal departmental structure and filled open positions, including new director.

Results: Met all annual operating plan goals.