APR 10, 2019 9:00 AM PDT

Validation and Implementation of Quantitative Molecular Assays

Sponsored by: DiaSorin Molecular LLC
Speaker

Abstract

Regulatory requirements for verification and validation are complex and often cause confusion among clinical laboratorians, especially in regards to quantitative molecular assays. This presentation will discuss verification and validation requirements as defined by the Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP). Calibrations and standards, including calibration, calibration verification, analytical measurement range (AMR) verification and the importance of quality standards, will also be discussed.

Learning Objectives: 

1. Define verification and validation
2. Define the verification requirements for unmodified FDA-cleared/approved tests
3. Discuss the validation requirements for modified FDA-cleared/approved tests and laboratory developed tests
4. Describe calibration methods and standards for quantitative assays


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APR 10, 2019 9:00 AM PDT

Validation and Implementation of Quantitative Molecular Assays

Sponsored by: DiaSorin Molecular LLC

Specialty

Molecular Diagnostics

Molecular Biology

Laboratory Testing

Clinical Diagnostics

Dna Sequencing

Immunology

Pcr/rt-Pcr/real-Time Pcr

Infectious Disease

Gene Sequencing

Dna

Genetics

Gene Expression

Microbiology

Next-Generation Sequencing

Clinical Research

Geography

North America65%

Asia19%

South America12%

Registration Source

Website Visitors100%

Job Title

Medical Laboratory Technician38%

Educator/Faculty14%

Executive14%

Lab Management10%

Clinical Laboratory Scientist5%

Facility/Department Manager5%

Microbiologist5%

Scientist5%

Marketing/Sales5%

Organization

Clinical Laboratory23%

Academic Institution19%

Hospital12%

Pharmaceutical Company8%

Manufacturer - Other4%

Diagnostic Company4%

Biotech Company4%

Medical Center4%

Research Institute4%

Government4%

Medical Device Company4%

Other8%


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