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Personal Information
Organization / Workplace
San Diego, California United States
Occupation
Sr. Director of Technical Operations / Co-Founder
Industry
Medical / Health Care / Pharmaceuticals
About
Over twenty four (26) years of experience in the quality assurance, pharmaceutical, biopharmaceutical, veterinarian products, and medical device industries. Expertise in Quality Systems, Quality Assurance and Computer and Equipment Validation including SOP development, risk assessments, quality reviews, protocol IQ/OQ/PQ development and execution, project management, outside vendor selection, development of project time lines, scheduling of outside vendor services, scheduling of in-house QA/ QC services, resolution of compliance issues, and QA batch and clinical data reviews. Specialties: Expertise in Quality Systems, Quality Assurance, Computer and Equipment Validation including SOP de...
Contact Details

Presentations(1)Ìý

Interpretation of Part 11 by the GxP Predicate Rules
Interpretation of Part 11 by the GxP Predicate RulesInterpretation of Part 11 by the GxP Predicate Rules
Interpretation of Part 11 by the GxP Predicate Rules
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Documents(1)Ìý

QCP Regulatory Flyer 2010
QCP Regulatory Flyer 2010QCP Regulatory Flyer 2010
QCP Regulatory Flyer 2010
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