Mark Tucker, LLC

Mark Tucker, LLC specializes in inspection management, inspection readiness, GMP training, and GMP auditing tailored to your your challenges and your people.  We believe that developing a robust compliance system is a competitive advantage and ensures ongoing inspection readiness.  Our goal is to assist you in not only being ready for an individual inspection, but to help you understand FDA's inspection approach and to develop your compliance system so that you are always "inspection ready."

       Inspection Management   
  • Inspection Management System Development
  • Pre Approval and GMP Inspection Preparation
  • Mock Audits
  • Inspection Responses


GMP Auditing

  • Audit Performance Metrics Development
  • GMP Training
  • GMP Compliance Audits


About Me

I have a degree in Biochemistry from W. M. Rice University and 20+ years experience in GMP Compliance, including Inspection Management and Auditing.  I worked at FDA as an Investigator, Analyst and Compliance Officer primarily in the drug area before becoming Director, Investigations Branch for Los Angeles District.

Upon leaving FDA, I joined Genentech, where I headed the GMP Compliance group responsible for conducting both internal and external GMP audits and the Corporate Inspection Management team responsible for inspection readiness processes, metrics, inspection preparation and inspection finding responses.  I also was a member of the Quality Leadership Team and provided annual GMP Training to the Genentech Senior Leadership teams.  I became Head, CMC QA in 2015 at Ultragenyx providing quality oversight of an external CMO network.

1001 Bridgeway, Suite 172, Sausalito, CA 94965     
      phone: +1 503 780 9886


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