Varsha Meghnani
Consultant | Director of Highly Complex Labs
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Credentials:PhD in Pharmaceutical Sciences, MS in Pharmacology And Toxicology, BS in Pharmacy
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Experience:High complexity laboratory director for more than 6 years. Startup Consultant for more than 100 labs nationwide. Experience in CAP, COLA, CLIA, CLSI, ISO, FDA guidelines, MolDx application. CAP inspector since year 2020. Experience in NGS, PCR, Molecular microbiology, Allergy testing, Blood chemistry, Hematology etc. Duties include: Method development, optimization, validation to determine the accuracy, precision, and other pertinent performance characteristics of the methods as per CLIA, COLA, CAP standards. Establish and implement appropriate quality control and quality assurance programs. Ensure the safe environmental condition of the lab. Ensure the laboratory’s enrollment in an HHS-approved proficiency testing program covering the entire test menu. Review and report proficiency testing results to the relevant program agency. Ensure that the policies and procedures are established for monitoring preanalytical, analytical, and postanalytical phases of testing. Competency evaluation of the lab staff to ensure they have appropriate training for the type and complexity of the services offered.
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States:Nationwide