Anne Marsden
Consultant
- Role
- Clinical Laboratory Consultant at Consultant
- Location
- San Juan Capistrano, CA, US
- LinkedIn followers
- 500 followers
About Anne Marsden
Committed to quality and regulatory compliance in the clinical laboratory.
Experience
Clinical Laboratory Consultant
Apr 2013 — Present · Orange County, CA, US
Available to provide consultation, technical writing and production of standard operating procedures. Reviews of clinical laboratory validations. Consultation in Clinical Laboratory Regulations. Specialties: Internal Audits, General Laboratory Regulations, CLIA, CMS, College of American Pathologists requirements (CAP), California Department of Health, CA CCR, Laboratory Personnel Licensure, NYS DOH, Florida, FDA, ISO 9001, ISO 13485, ISO 15189, 21 CFR Part 11, Six Sigma Green Belt, CAPA, LIMS, 21 CFR Part 820, SOP writing/editing, FMEA, Root Cause Analysis, extensive laboratory Clinical Trials QA experience.
Education
Queen Mary University of London
Bachelor of Science (B.Sc.), Genetics
1976 — 1979
Skills
- Healthcare
- Pharmaceutical Industry
- Infectious Diseases
- Quality System
- Change Control
- Healthcare Information Technology
- Quality Assurance
- Consultant Clinical Laboratory Quality and Regulatory Afffairs
- Laboratory Medicine
- Commercialization
- Medical Devices
- Blood Bank
- Clinical Trials
- Ehr
- Computer System Validation
- Medical Technology
- Life Sciences
- Validation
- Gcp
- Lifesciences
- 21 Cfr Part 11
- Lims
- V&V
- Glp
- Hospitals
- Microbiology
- Pathology
- Elisa
- Capa
- Hardware Diagnostics
- Molecular Diagnostics
- Fda
- Sop
- Hipaa
- Quality Control
- Immunoassays
- Iso 13485
- Informatics
- Regulatory Affairs
- Assay Development
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