Mark Tucker, LLC
Inspection Management
and GMP Expert
Mark Tucker, Ph. D. has a degree in Biochemistry from W. M. Rice University and over 15 years experience in Inspection Management and Auditing.
He 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 and joining Genentech, he headed the GMP Compliance group responsible for conducting both internal and external GMP audits and the Corporate Inspection Management team responsible for inspection readiness metrics, inspection preparation and developing finding responses. He also provided annual GMP Training to the Genentech Leadership teams.
Dr. Tucker has also provided Inspection Training in Europe and China, covering preparation for biotech Pre Approval Inspections.
SERVICES INCLUDE
Inspection Management
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-Inspection Management System Development
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-Pre Approval and Inspection Preparation
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-Mock Audits
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-Inspection Responses
GMP Auditing
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-Audit Performance Metrics Development
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-GMP Training
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-GMP Compliance Audit Training
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-GMP Compliance Audits
CONTACT INFO
Address: 333 NW 9th Avenue, Suite 912
Portland, OR 97209
Phone: +1 503 780 9886
Email: no483@marktuckerllc.com
My LinkedIn
Mark Tucker, Ph. D., President